273 Clinical Trials for Various Conditions
This is a Phase I/II study to determine the safety and immune response of the H1299 cell lysate vaccine mixed with Montanide(R) ISA-51 VG adjuvant, to be administered on the study in combination with Entinostat and Nivolumab in eligible participants with locally advanced esophageal cancers (EsC) following either neoadjuvant chemoradiation therapy (nCRT) or nCRT and surgery. Phase I of the protocol aims to determine the safe dose of the H1299 lung cancer cell lysate vaccine mixed with Montanide(R) ISA-51 VG adjuvant when it is administered in combination with Entinostat and Nivolumab. Phase II of the protocol will focus on assessing the level of immune response in participants receiving the study intervention when the H1299 cell lysate vaccine with Montanide(R) ISA-51 VG adjuvant is administered at the dose level determined in Phase I.
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.
Background: In published studies, complete response (CR) to chemoradiation occurs in only 25-30% of patients with locally advanced esophageal cancer. Liquid nitrogen spray cryotherapy (LNSC) is postulated to stimulate an anti-tumor immune response. In a preliminary study, the investigators documented CR rate of 56% with a single session of LNSC administered prior to chemoradiation. Before proceeding with larger trials to corroborate these findings, the maximally tolerated dose (MTD) of neoadjuvant LNSC must be determined. The aims of this study are: (1) To determine safety and MTD of LNSC during neoadjuvant chemoradiation in locally advanced esophageal cancer. (2) To assess whether LNSC results in immunogenic cell death. (3) To assess changes in tumor micro-environment with LNSC. Methods: Eligible adult patients with locally advanced esophageal cancer will receive LNSC at the following dose frequencies: Patient 1, 2, and 3: 2 sessions of LNSC prior to chemoradiation (chemoXRT); Patients 4, 5, and 6: 2 sessions LNSC prior to chemoXRT, then 1 session during week 4 of chemoXRT; Patients 7, 8, and 9: 2 sessions LNSC prior to chemoXRT, then 1 session during week 2 and 1 session during week 4 of chemoXRT. If no dose limiting toxicity (DLT) occurs, the investigators will enroll an additional 3 patients to confirm MTD. The investigators will contact patients at 48-hours and 1-week post-procedure to evaluate for adverse events (AEs) and DLTs, and assess for improvements in dysphagia and quality of life (QOL) using the Mellow-Pinkas and EORTC QLQ-OES18 instruments respectively. The investigators will obtain peripheral blood for ELISA and biopsies from the tumor to assess tumor-infiltrating lymphocytes (TILs) and T cell subtypes before the 1st session of LNSC, before the 2nd session of LNSC, and after chemoradiation is completed. Expected results: (1) Dose limiting toxicity (DLT) does not occur when patients received 2 session of LNSC prior to chemoXRT, and 2 sessions during chemoXRT (2) LNSC results in immunogenic cell death, as assessed by increased levels of HMGB1 in serum, and calreticulin in biopsy specimens (CRT) (3) LNSC is associated with increased T cell infiltration and activation (increased TILs, CD8+, CD3+ T cells, and granzyme B), and decrease in regulatory T cells (CD45R0, FOXP3).
Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer.
This research study is studying a targeted therapy as a possible treatment for advanced esophageal cancer. The study intervention involved in this study is: -Pembrolizumab
Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with esophageal cancer present with tumors which are not amenable to surgery and are treated with chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer is dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2 months for swallowing to improve with this treatment. Another method of shrinking esophageal tumors and allowing for better swallowing is endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of an endoscope); cryotherapy is a well established method for treating cancerous and pre-cancerous esophageal disease. This is a particularly attractive treatment option, as patients with esophageal cancer usually undergo endoscopy on several occasions before starting treatment in order to biopsy and evaluate the tumor. The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC related dysphagia in patients who are getting ready to start chemotherapy and radiation. In order to do this the investigators are planning to invite patients who are already undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo cryotherapy after the diagnostic portion of the endoscopy has been completed. After the cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2 and 4 weeks after cryotherapy.
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.
Patients with esophageal and gastroesophageal junction (GEJ) cancer often have weight loss, swallowing problems, and poor appetite. This may affect their ability to tolerate cancer treatment. The purpose of this study is to see if the researchers can apply a set of nutrition guidelines designed specifically for patients with cancer who are older than 65 years of age. The questions will allow them to assess the nutritional status and make appropriate referrals. If the patients are having swallowing problems or losing weight, the researchers want to address the nutritional problems early in the course of their treatment.
The purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer.
RATIONALE: Monoclonal antibodies, such as panitumumab, 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. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with panitumumab and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel, cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed, locally advanced esophageal cancer or cancer of the gastroesophageal junction.
Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens. Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when combined with chemotherapy, as demonstrated with other regimens in similar settings. We believe that the combination of paclitaxel and sunitinib malate offer great promise in the treatment of advanced esophageal cancer.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, 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. 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. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer. PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan 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. Irinotecan and docetaxel may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with irinotecan and radiation therapy with or without cisplatin in treating patients with locally advanced esophageal cancer.
To study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating the acute and late toxicity of treatment.
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, 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 bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of esophageal cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and monoclonal antibody therapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving irinotecan, cisplatin, and bevacizumab together with radiation therapy followed by surgery and bevacizumab works in treating patients with locally advanced esophageal cancer.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced esophageal cancer.
RATIONALE: 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. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, 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 cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.
The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.
Background: Previously we have demonstrated induction of tumor antigen and tumor suppressor gene expression in lung cancer cells following exposure to the DNA demethylating agent, Decitabine (DAC). We have also demonstrated that DAC mediated target gene expression and apoptosis can be significantly enhanced in cancer cells by subsequent exposure to the histone deacetylase (HDAC) inhibitor Depsipeptide FK228 (DP). Furthermore, we have demonstrated that following DAC, or DAC/DP exposure, cancer cells can be recognized by cytolytic T cells specific for the cancer testis antigen, NY-FSO-1. This Phase I study will evaluate gene induction in thoracic oncology patients mediated by sequential DAC/DP treatment with or without the selective COX-2 inhibitor, celecoxib. Objectives: Evaluation of the pharmacokinetics and toxicity of continuous 72-hour intravenous Decitabine (DAC) infusion followed by 4-hour intravenous infusion of Depsipeptide FK228 (DP) with or without oral celecoxib in patients with unresectable cancers involving the lungs or pleura. Analysis of NY-ESO-1, p16 and p21 expression in cancer specimens before and after sequential Decitabine/Depsipeptide treatment. Analysis of serologic response to NY-ESO-1 before and after sequential drug treatment. Analysis of apoptosis in tumor biopsies before and after sequential Decitabine/Depsipeptide treatment. Refinement of laser capture microdissection and micro-array techniques for analysis of gene expression profiles in tumor tissues. Eligibility: Patients with histologically or cytologically proven primary small cell or non-small cell lung cancers, advanced esophageal cancers, pleural mesotheliomas, or non-thoracic cancers with metastases to the lungs or pleura. Patients must be 18 years or older with an ECOG performance status of 0-2 and have adequate pulmonary reserve evidenced by FEV1 and DLCO greater than the 30% predicted, and less than 50 mm Hg and p02 greater than 60 mm Hg on room air ABG. Patients must have a platelet count greater than 100.000. an ANC equal to or greater than 1500 without transfusion or cytokine support, a normal PT, and adequate hepatic function as evidenced by a total bilirubin of less than 1.5 x upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2). Design: Patients with inoperable malignancies involving lungs or pleura will receive two cycles of 72-hour intravenous infusion of Decitabine followed by 4-hour Depsipeptide infusion using a Phase I study design. Decitabine will be administered by continuous infusion on days 1-4, and patient cohorts will receive escalating doses of Depsipeptide administered on day 4 and day 10 of a 34 day cycle. Once the MTD and toxicities for sequential DAC/DP have been identified, additional cohorts of 6 lung cancer patients and 6 mesothelioma patients will receive sequential DAC/DP administered at the MTD as outlined above with celecoxib (400mg bid) administered on days 4-34 of each treatment cycle, as a means to enhance target cell apoptosis and facilitate anti-tumor immune recognition/response. Pharmacokinetics, systemic toxicity, and response to therapy will be recorded. Tumor biopsies will be obtained prior to, and after therapy to evaluate expression of NY-ESO-1 tumor antigen, as well as p16 and p21 tumor suppressor genes, which are known to be modulated by chromatin structure. Additional analysis will be undertaken to evaluate the extent of apoptosis in tumor tissues, and to determine if immune recognition of NY-ESO-1 can be demonstrated following sequential DAC?DP +/- celecoxib treatment. As the exact set of comparisons and analyses to be performed will be determined following completion of the trial and will be based on limited numbers of patients, the analyses will be considered exploratory and hypothesis generating rather than definitive. A total of 40 patients will be enrolled.
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors
The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response. All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).
The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.
This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.
A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)