1,838 Clinical Trials for Various Conditions
RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future. PURPOSE: This laboratory study is looking at biomarkers in patients with respiratory tract dysplasia or lung cancer, head and neck cancer, or aerodigestive tract cancer.
RATIONALE: Gathering information about patients' quality of life during radiation therapy for cancer may help doctors plan the best treatment. PURPOSE: This randomized clinical trial is studying quality of life in patients undergoing radiation therapy for primary lung cancer, head and neck cancer, or gastrointestinal cancer.
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Erlotinib hydrochloride 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. Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more tumor cells.
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)
The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).
The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.
This study aims to determine the feasibility of non-invasive quantitative PD-L1 measurement using \[a novel PD-L1 positron emission tomography (PET) tracer and perform immunohistochemistry based measurement of PD-L1 levels within resected lesions in head and neck cancer and brain metastases.
The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx.
The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) \>=1 R/M HNSCC.
Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved ponatinib for use in patients, including people with your type of cancer. In order to participate on this study, it must first be determined whether or not a patient's lung or head and neck squamous cell cancer (SCC) has an alteration in FGFR kinase is made from an experimental test on your squamous cell cancer tissue sample. This experimental test is a "genetic test" or "genotyping test", which is a method used to study a tumor's genes. The results are for research purposes only and are not considered "genetic testing" for the purpose of diagnosing medical conditions. Cancers develop as a result of changes that occur in human genetic material (DNA); these changes are called mutations or alterations. This experimental test gives no information about any of the genes in the normal cells of the patient's body, but it helps identify abnormal genes (like FGFR kinase mutations or alterations) usually found only in cancer cells. We will use this experimental test to determine whether or not a tumor contains a required alteration/mutation and thus may respond to ponatinib. Ponatinib is an investigational, oral anti-cancer drug designed to inhibit abnormal proteins found in cancer cells and may cause those cancer cells to die. In laboratory testing, ponatinib has been shown to inhibit a family of proteins called FGFR kinases, and this genetic alteration/mutation has been found in some squamous cell lung cancers. There is laboratory evidence that alterations/mutations in FGFR kinases in squamous cell lung cancers may be driving the growth of these tumors and that inhibiting these FGFR kinases with ponatinib may decrease or stop the growth of lung SCC. In this research study, we are looking to see if the study drug, ponatinib, can keep cancer from growing.
This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg, MET, VEGFR2/kinase insert domain receptor \[KDR\]). Since MET overexpression has been associated with poorer prognosis and MET tyrosine kinase mutations have been reported in SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may be of therapeutic benefit in this patient population.
This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.
This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.
This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.
The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT) in standard of care (SOC) use in the treatment of local,loco-regionally advanced, and oligometastatic malignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including a collection of dosimetric data will also be analyzed.
The purpose of the present research protocol is to investigate and identify translocator protein 18kDa, MRI DTI, and EEG/ERPs, markers of Chronic Systemic Symptoms (CSS).
VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally encounter significant disparities in accessing care for their mental health needs while undergoing toxic treatments that provide considerable physical and emotional stress. Thus, the investigators propose to adapt evidence-based strategies to a stepped-care intervention model to address the mental health needs of under-served lung cancer (LC) and head and neck cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g., mild, moderate, or severe symptoms of depression and anxiety).
In this trial, the objectives are to determine the efficacy and toxicity of induction chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm 2: A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin, and 5-FU (APF). The investigators also hypothesize that the high anti-tumor efficacy of nab-paclitaxel in HNSCC is due to the upregulation of macropinocytosis, a result of the frequent presence of Ras and PI3K (and epidermal growth factor receptor -EGFR) activation in this cancer. Amendment to Add Arm 3: In this amendment, the investigators retain the AP + concurrent chemoradiation therapy (CRT) backbone but de-escalate the dose of radiation therapy (RT) from 70 Gy to 42 Gy. The investigators also plan to administer one dose (vs three) of cisplatin during RT. This novel treatment approach will be evaluated in patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) (Arm 3), a sub-group with a very favorable prognosis.
This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.
The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.
Currently, appropriate patients undergo MRI imaging with immobilization and sequences optimized for diagnostic radiology purposes. Using a mutual information algorithm, these images are then registered to a treatment planning CT obtained with custom immobilization to minimize intra-and inter-treatment motion and positional variation. This image registration process is time-consuming and introduces additional layers of geometric uncertainty into what should be a highly precise treatment planning process. However, it is necessary, since radiation dose calculations cannot be performed on MRI data due to the lack of crucial density information. The investigator envisions CT-less treatment planning, using only MRI, due to superior imaging characteristics, fully integrated into the radiation oncology clinic. This study will begin this process.
The purpose of this study is to test the preventive effects of a combination of drugs: polyphenon E (PPE) derived from green tea extracts, and erlotinib. Because this combination of drugs has not been tested in humans before for the prevention of cancer, it is not clear which dose of each agent will be optimal in combination. We will test the safety of the combination of PPE and erlotinib and see what effects (good and/or bad) it has on the patient's premalignant lesion, and find the highest dose of each agent that can be given in combination without causing severe side effects.
The objectives for this study is as follows: * Primary: * To evaluate the progression-free survival of locoregionally advanced (stages III/IV) SCCHN patients undergoing postoperative chemoradiotherapy with panitumumab. * Secondary: * To evaluate the overall survival, event-free survival, and toxicities. * To correlate efficacy parameters with 1) EGFR and downstream pathway activation, 2) FcyR polymorphisms, and 3) serum cytokine profiles. More specifically, the aim is to demonstrate the usefulness of biomarkers (downstream signaling molecules, FcyR polymorphisms, or tumor and serum cytokine(s) in predicting progression-free survival in patients with SCCHN treated with the above treatment. Specific biomarkers that relate to Epidermal Growth Factor Receptor and angiogenesis, including EGFR, pEGFR, Src, pMAPK, pSTAT3, pSTAT5, pSTAT1, pAKT, p38, p21, p27, PARP, E-cadherin, p-ErbB3, Ki67, VEGF, and IL-8, using reverse phase protein microarrays (RPPA) will be tested in baseline archival paraffin-embedded tumor tissue. To collect tumor tissue from pretreatment biopsies for cytokine/chemokine and immune biomarker studies on tumor tissue. We plan to investigate the expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers. In addition, EGFR polymorphisms will be studied in tumor tissue samples and serum. Additional studies may be performed in the future. Some of these studies may be performed by Amgen.
In this Phase I B/II trial, we seek to determine the safety and efficacy of sorafenib with standard dose cetuximab in the treatment of patients with Recurrent and /or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).
The purpose of this study is to evaluate the prevalence of esophageal pathology in asymptomatic patients with a history of head and neck cancer.
The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.
This clinical trial studies how well intensity modulated proton therapy (IMPT) or intensity modulated X-ray (radiation) therapy (IMRT) works after surgery in treating patients with head and neck cancer. IMPT is a type of radiation therapy that allows for the most accurate application of proton radiation to the tumor and has the potential to reduce treatment-related side effects. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of x-ray radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. IMPT may work as well as IMRT after surgery in treating patients with head and neck cancer.
This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.