Treatment Trials

191 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
TMV Vaccine Therapy Alone and with Pembrolizumab for the Treatment of Recurrent And/or Metastatic Head and Neck Squamous Cell Cancer
Description

This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and/or effective in treating patients with recurrent and/or metastatic head and neck squamous cell cancer.

RECRUITING
Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation
Description

This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation.

Conditions
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Cutaneous Squamous Cell Carcinoma of the Head and NeckHead and Neck Carcinoma of Unknown PrimaryHead and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaMetastatic Cutaneous Squamous Cell Carcinoma of the Head and NeckMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Nasopharyngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaMetastatic Paranasal Sinus Squamous Cell CarcinomaNasopharyngeal Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaParanasal Sinus Squamous Cell CarcinomaRecurrent Cutaneous Squamous Cell Carcinoma of the Head and NeckRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Nasopharyngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Paranasal Sinus Squamous Cell CarcinomaStage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Nasopharyngeal Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Sinonasal Cancer AJCC v8
RECRUITING
Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
Description

This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.

ACTIVE_NOT_RECRUITING
Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer
Description

This early-phase trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past (previously untreated), has spread to nearby tissue or lymph nodes (locally advanced) and cannot receive cisplatin (cisplatin-ineligible). Tolinapant may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tolinapant and radiation therapy may kill more tumor cells.

ACTIVE_NOT_RECRUITING
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Description

This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced stage) or has come back after prior treatment (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Cisplatin and carboplatin are in a class of chemotherapy medications known as platinum-containing compounds. They work by killing, stopping, or slowing the growth of cancer cells. Docetaxel is in a class of chemotherapy medications called taxanes. It stops cancer cells from growing and dividing and may kill them. The addition of bevacizumab to standard chemotherapy or combination therapy with bevacizumab and atezolizumab may be better than standard chemotherapy plus cetuximab in treating patients with recurrent/metastatic head and neck cancers.

COMPLETED
Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer
Description

This phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. The change in dose radiation frequency and dose investigated in this study may help to better control the tumor and prevent it from coming back or growing. The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence (the tumor comes back after treatment).

ACTIVE_NOT_RECRUITING
Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma
Description

This phase I trial studies the side effects and best dose of birinapant when given together with intensity modulated re-irradiation therapy (IMRRT) in treating patients with head and neck squamous cell carcinoma that has come back at or near the same place as the original (primary) tumor (locally recurrent). Birinapant may stop the growth of tumor cells by blocking inhibitor of apoptosis (IAP), a protein needed for tumor cell survival. IMRRT uses thin beams of radiation of different intensities that are aimed at the tumor from many angles. This type of re-irradiation therapy reduces the damage to healthy tissue near the tumor. Giving birinapant with IMRRT may lower the chance of head and neck squamous cell carcinoma growing or spreading.

WITHDRAWN
ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer
Description

RATIONALE: A specially modified virus called ONYX-015 may be able to kill tumor cells while leaving normal cells undamaged. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ONYX-015 with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of ONYX-015 combined with cisplatin and fluorouracil in treating patients who have advanced head and neck cancer.

COMPLETED
Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer
Description

This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells.

COMPLETED
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Description

This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.

TERMINATED
Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer
Description

This phase III trial compares the effect of adding nivolumab to the usual chemotherapy (cisplatin or carboplatin with gemcitabine) versus standard chemotherapy alone in treating patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab with the usual chemotherapy may work better than the standard chemotherapy alone in treating patients with nasopharyngeal cancer.

COMPLETED
Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma
Description

This randomized phase II trial studies how well ficlatuzumab with or without cetuximab works in treating patients with head and neck squamous cell carcinoma that has come back or spread to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and reproduce, and helps the immune system recognize and fight head and neck squamous cell carcinoma.

TERMINATED
Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer
Description

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy (SBRT) in treating participants with head and neck cancer that has spread from where it started to nearby tissue or lymph nodes and is at high risk for continuing to spread because the participant cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a specialized radiation therapy that delivers radiation directly to the tumor in smaller doses over several days, which may kill more tumor cells and cause less damage to normal tissue.

COMPLETED
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
Description

This phase II trial studies how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving temsirolimus together with cetuximab is more effective than giving temsirolimus alone.

Conditions
Recurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Laryngeal Verrucous CarcinomaRecurrent Lip and Oral Cavity Squamous Cell CarcinomaRecurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult PrimaryRecurrent Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaRecurrent Nasopharyngeal Keratinizing Squamous Cell CarcinomaRecurrent Oral Cavity Verrucous CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Salivary Gland CarcinomaSalivary Gland Squamous Cell CarcinomaSquamous Cell Carcinoma Metastatic in the Neck With Occult PrimaryStage IV Hypopharyngeal Squamous Cell CarcinomaStage IV Nasopharyngeal Keratinizing Squamous Cell CarcinomaStage IVA Laryngeal Squamous Cell CarcinomaStage IVA Laryngeal Verrucous CarcinomaStage IVA Lip and Oral Cavity Squamous Cell CarcinomaStage IVA Major Salivary Gland CarcinomaStage IVA Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaStage IVA Oral Cavity Verrucous CarcinomaStage IVA Oropharyngeal Squamous Cell CarcinomaStage IVB Laryngeal Squamous Cell CarcinomaStage IVB Laryngeal Verrucous CarcinomaStage IVB Lip and Oral Cavity Squamous Cell CarcinomaStage IVB Major Salivary Gland CarcinomaStage IVB Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaStage IVB Oral Cavity Verrucous CarcinomaStage IVB Oropharyngeal Squamous Cell CarcinomaStage IVC Laryngeal Squamous Cell CarcinomaStage IVC Laryngeal Verrucous CarcinomaStage IVC Lip and Oral Cavity Squamous Cell CarcinomaStage IVC Major Salivary Gland CarcinomaStage IVC Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaStage IVC Oral Cavity Verrucous CarcinomaStage IVC Oropharyngeal Squamous Cell CarcinomaTongue Carcinoma
COMPLETED
Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer
Description

This phase I trial studies the side effects and the best dose of lenalidomide when given together with cetuximab in treating patients with colorectal cancer or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Giving lenalidomide together with cetuximab may be a better treatment for colorectal cancer or head and neck cancer.

Conditions
Recurrent Colon CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Laryngeal Verrucous CarcinomaRecurrent Lip and Oral Cavity Squamous Cell CarcinomaRecurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult PrimaryRecurrent Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaRecurrent Nasopharyngeal Keratinizing Squamous Cell CarcinomaRecurrent Oral Cavity Verrucous CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Rectal CarcinomaRecurrent Salivary Gland CarcinomaSalivary Gland Squamous Cell CarcinomaSquamous Cell Carcinoma Metastatic in the Neck With Occult PrimaryStage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7Stage IVA Colon Cancer AJCC v7Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVA Laryngeal Verrucous Carcinoma AJCC v7Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Major Salivary Gland Cancer AJCC v7Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7Stage IVA Oral Cavity Cancer AJCC v6 and v7Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVA Rectal Cancer AJCC v7Stage IVB Colon Cancer AJCC v7Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVB Laryngeal Verrucous Carcinoma AJCC v7Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVB Major Salivary Gland Cancer AJCC v7Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7Stage IVB Oral Cavity Cancer AJCC v6 and v7Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVB Rectal Cancer AJCC v7Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVC Laryngeal Verrucous Carcinoma AJCC v7Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVC Major Salivary Gland Cancer AJCC v7Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7Stage IVC Oral Cavity Cancer AJCC v6 and v7Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7Tongue Carcinoma
COMPLETED
Cediranib Maleate in Treating Patients With Recurrent or Newly Diagnosed Metastatic Head and Neck Cancer
Description

This phase II trial is studying how well cediranib maleate works in treating patients with recurrent or newly diagnosed metastatic head and neck cancer. Cediranib maleate may stop the growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

ACTIVE_NOT_RECRUITING
Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma
Description

This phase I trial studies the side effects and best dose of vorinostat when given together with azacitidine in treating patients with nasopharyngeal cancer or nasal natural killer T-cell lymphoma that has recurred (come back) at or near the same place as the original (primary) tumor, usually after a period of time during which the cancer could not be detected or has spread to other parts of the body. Drugs used in chemotherapy, such as vorinostat and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vorinostat and azacitidine also may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with azacitidine may kill more cancer cells.

RECRUITING
RAPA-201 Therapy of Solid Tumors
Description

The therapy of solid tumors has been revolutionized by immune therapy, in particular, approaches that activate immune T cells in a polyclonal manner through blockade of checkpoint pathways such as PD-1 by administration of monoclonal antibodies. In this study, the investigators will evaluate the adoptive transfer of RAPA-201 cells, which are checkpoint-deficient polyclonal T cells that represent an analogous yet distinct immune therapy treatment platform for solid tumors. The administration of polyclonal, metabolically-fit RAPA-201 cells is a novel adoptive T cell therapy approach that is suitable for regenerative medicine efforts. RAPA-201 is a novel immunotherapy product consisting of reprogrammed autologous CD4+ and CD8+ T cells of Th1/Tc1 cytokine phenotype. RAPA-201, which have acquired resistance to the mTOR inhibitor temsirolimus, are manufactured ex vivo from peripheral blood mononuclear cells collected from solid tumor patients using a steady-state apheresis. The novel RAPA-201 manufacturing platform, which incorporates both an mTOR inhibitor (temsirolimus) and an anti-cancer Th1/Tc1 polarizing agent (IFN-alpha) generates polyclonal T cells with five key characteristics: 1. Th1/Tc1: polarization to anti-cancer Th1 and Tc1 subsets, with commensurate down-regulation of immune suppressive Th2 and regulatory T (TREG) subsets; 2. T Central Memory: expression of a T central memory (TCM) phenotype, which promotes T cell engraftment and persistence for prolonged anti-tumor effects; 3. Rapamycin-Resistance: acquisition of rapamycin-resistance, which translates into a multi-faceted anti-apoptotic phenotype that improves T cell fitness in the stringent conditions of the tumor microenvironment; 4. T Cell Quiescence: reduced T cell activation, as evidence by reduced expression of the IL-2 receptor CD25, which reduces T cell-mediated cytokine toxicities such as cytokine-release syndrome (CRS) that limit other forms of T cell therapy; and 5. Reduced Checkpoints: multiple checkpoint inhibitory receptors are markedly reduced on RAPA-201 cells (including but not limited to PD-1, CTLA4, TIM-3, LAG3, and LAIR1), which increases T cell immunity in the checkpoint-replete, immune suppressive tumor microenvironment. This is a non-randomized, open label, multi-site, phase I/II trial of outpatient RAPA-201 immune T cell therapy in patients with advanced metastatic, recurrent, and unresectable solid tumors that have recurred or relapsed after prior immune therapy. Patients must have tumor relapse after at least one prior line of therapy and must have refractory status to the most recent regimen, which must include an anti-PD-(L)1 monoclonal antibody. Furthermore, accrual focuses upon solid tumor disease types potentially amenable to standard-of-care salvage chemotherapy consisting of the carboplatin + paclitaxel (CP) regimen that will be utilized for host conditioning prior to RAPA-201 therapy. Importantly, carboplatin and paclitaxel are "immunogenic" chemotherapy agents whereby the resultant cancer cell death mechanism is favorable for generation of anti-tumor immune T cell responses. Thus, the CP regimen that this protocol incorporates is intended to directly control tumor progression and indirectly promote anti-tumor T cell immunity. Protocol therapy consists of six cycles of standard-of-care chemotherapy (carboplatin + paclitaxel (CP) regimen) administered in the outpatient setting every 28 days (chemotherapy administered on cycles day 1, 8, and 15). RAPA-201 cells will be administered at a target flat dose of 400 X 10\^6 cells per infusion on day 3 of cycles 2 through 6. In the original protocol design, a sample size of up to 22 patients was selected to determine whether RAPA-201 therapy, when used in combination with the CP regimen, represents an active regimen in solid tumors that are resistant to anti-PD(L)-1 checkpoint inhibitor therapy, as defined by a response rate (≥ PR) consistent with a rate of 35%. The first stage of protocol accrual consisted of n=10 patients; to advance to the second protocol accrual stage (accrual of an additional n=12 patients), RAPA-201 therapy must result in a tumor response (≥ PR) in at least 2 out of the 10 initial patients. As described below in the detailed description, this original protocol implementation demonstrated that RAPA-201 represented an active treatment regimen for solid tumor patients, and as such, the protocol was expanded to evaluate the combination of RAPA-201 therapy followed by anti-PD1 maintenance therapy.

COMPLETED
Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Description

This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

COMPLETED
Circulating Tumor DNA in Predicting Outcomes in Patients With Stage IV Head and Neck Cancer or Stage III-IV Non-small Cell Lung Cancer
Description

This pilot research trial studies circulating tumor deoxyribonucleic acid (DNA) in predicting outcomes in patients with stage IV head and neck cancer or stage III-IV non-small cell lung cancer. Studying circulating tumor DNA from patients with head and neck or lung cancer in the laboratory may help doctors predict how well patients will respond to treatment.

COMPLETED
Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Description

This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen saliva thickness and painful mouth sores in patients with head and neck cancer undergoing radiation therapy. Side effects from radiation therapy to the head and neck, such as thickened saliva and mouth sores, may interfere with activities of daily living such as eating and drinking, and may also cause treatment to be stopped or delayed. Acetylcysteine rinse may reduce saliva thickness and mouth sores, and improve quality of life in patients with head and neck cancer undergoing radiation therapy.

Conditions
MucositisOral ComplicationsRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Basal Cell Carcinoma of the LipRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage I Adenoid Cystic Carcinoma of the Oral CavityStage I Basal Cell Carcinoma of the LipStage I Lymphoepithelioma of the NasopharynxStage I Lymphoepithelioma of the OropharynxStage I Mucoepidermoid Carcinoma of the Oral CavityStage I Salivary Gland CancerStage I Squamous Cell Carcinoma of the LarynxStage I Squamous Cell Carcinoma of the Lip and Oral CavityStage I Squamous Cell Carcinoma of the NasopharynxStage I Squamous Cell Carcinoma of the OropharynxStage I Verrucous Carcinoma of the LarynxStage I Verrucous Carcinoma of the Oral CavityStage II Adenoid Cystic Carcinoma of the Oral CavityStage II Basal Cell Carcinoma of the LipStage II Lymphoepithelioma of the NasopharynxStage II Lymphoepithelioma of the OropharynxStage II Mucoepidermoid Carcinoma of the Oral CavityStage II Salivary Gland CancerStage II Squamous Cell Carcinoma of the LarynxStage II Squamous Cell Carcinoma of the Lip and Oral CavityStage II Squamous Cell Carcinoma of the NasopharynxStage II Squamous Cell Carcinoma of the OropharynxStage II Verrucous Carcinoma of the LarynxStage II Verrucous Carcinoma of the Oral CavityStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Basal Cell Carcinoma of the LipStage III Lymphoepithelioma of the NasopharynxStage III Lymphoepithelioma of the OropharynxStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Lymphoepithelioma of the NasopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Adenoid Cystic Carcinoma of the Oral CavityStage IVA Basal Cell Carcinoma of the LipStage IVA Lymphoepithelioma of the OropharynxStage IVA Mucoepidermoid Carcinoma of the Oral CavityStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Adenoid Cystic Carcinoma of the Oral CavityStage IVB Basal Cell Carcinoma of the LipStage IVB Lymphoepithelioma of the OropharynxStage IVB Mucoepidermoid Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Adenoid Cystic Carcinoma of the Oral CavityStage IVC Basal Cell Carcinoma of the LipStage IVC Lymphoepithelioma of the OropharynxStage IVC Mucoepidermoid Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer
COMPLETED
Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Description

This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and docetaxel when given together with cisplatin and to see how well they work in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also help cisplatin and docetaxel work better by making tumor cells more sensitive to the drugs. Giving sorafenib tosylate, cisplatin, and docetaxel may be an effective treatment for squamous cell carcinoma of the head and neck.

Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySalivary Gland Squamous Cell CarcinomaStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Oral Cavity Squamous Cell CarcinomaStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue CancerUntreated Metastatic Squamous Neck Cancer With Occult Primary
COMPLETED
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer
Description

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin followed by chemoradiation in treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by chemoradiation therapy may be an effective treatment for head and neck cancer.

COMPLETED
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Description

This pilot randomized phase I/II trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with cetuximab and to see how well it works in treating patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may kill more tumor cells

Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySalivary Gland Squamous Cell CarcinomaStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer
TERMINATED
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
Description

This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more effective than a placebo in reducing mucositis

COMPLETED
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
Description

This phase I trial studies the side effects and best dose of cetuximab when given together with everolimus in treating patients with metastatic or recurrent colon cancer or head and neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus may be an effective treatment for colon cancer or head and neck cancer

Conditions
Recurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Basal Cell Carcinoma of the LipRecurrent Colon CancerRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Basal Cell Carcinoma of the LipStage IV Lymphoepithelioma of the NasopharynxStage IV Lymphoepithelioma of the OropharynxStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityStage IVA Colon CancerStage IVA Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IVA Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IVA Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Colon CancerStage IVB Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IVB Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IVB Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IVC Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IVC Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityTongue Cancer
TERMINATED
Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
Description

This phase I trial studies how well talactoferrin works in treating patients with relapsed or refractory non-small cell lung cancer (NSCLC) or squamous cell head and neck cancer. Biological therapies, such as talactoferrin, may stimulate the immune system in different ways and stop tumor cells from growing

Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySalivary Gland Squamous Cell CarcinomaStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Non-small Cell Lung CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer
COMPLETED
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
Description

This randomized phase I/II trial studies the side effects and best way to give lyophilized black raspberries in preventing oral cancer in high-risk patients previously diagnosed with stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer. Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from patients receiving lyophilized black raspberries may help doctors learn more about changes that occur in DNA and the effect of lyophilized back raspberries on biomarkers.

Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaSalivary Gland Squamous Cell CarcinomaStage 0 Hypopharyngeal CancerStage 0 Laryngeal CancerStage 0 Lip and Oral Cavity CancerStage 0 Nasopharyngeal CancerStage 0 Oropharyngeal CancerStage 0 Paranasal Sinus and Nasal Cavity CancerStage I Salivary Gland CancerStage I Squamous Cell Carcinoma of the HypopharynxStage I Squamous Cell Carcinoma of the LarynxStage I Squamous Cell Carcinoma of the Lip and Oral CavityStage I Squamous Cell Carcinoma of the NasopharynxStage I Squamous Cell Carcinoma of the OropharynxStage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage I Verrucous Carcinoma of the LarynxStage I Verrucous Carcinoma of the Oral CavityStage II Salivary Gland CancerStage II Squamous Cell Carcinoma of the HypopharynxStage II Squamous Cell Carcinoma of the LarynxStage II Squamous Cell Carcinoma of the Lip and Oral CavityStage II Squamous Cell Carcinoma of the NasopharynxStage II Squamous Cell Carcinoma of the OropharynxStage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage II Verrucous Carcinoma of the LarynxStage II Verrucous Carcinoma of the Oral CavityStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Oral Cavity Squamous Cell CarcinomaStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Nasal Cavity and Paranasal Sinus CancerStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Oral Cavity Squamous Cell CarcinomaStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Oral Cavity Squamous Cell CarcinomaStage IVC Squamous Cell Carcinoma of the OropharynxParanasal Sinus and Nasal Cavity Squamous Cell CarcinomaStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer
COMPLETED
TLR8 Agonist VTX-2337 and Cetuximab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Squamous Cell Cancer of Head and Neck
Description

This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when given together with cetuximab in treating patients with locally advanced, recurrent, or metastatic squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving TLR8 Agonist VTX-2337 together with cetuximab may kill more tumor cells.

Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySalivary Gland Squamous Cell CarcinomaStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer
COMPLETED
Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer
Description

This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and erlotinib hydrochloride together works in treating patients with metastatic or recurrent squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with cetuximab and erlotinib hydrochloride may kill more tumor cells.