View clinical trials related to Head and Neck Neoplasms.
Filter by:This study is a randomized, double-blind, sham-controlled, two-arm study conducted in subjects receiving chemoradiation therapy for the treatment of head and neck cancer to assess the efficacy of MuGard. The study will evaluate the ability of MuGard to reduce the symptoms of oral mucositis. The study includes a treatment period of approximately 7 weeks depending on the subject's prescribed radiation plan. MuGard is a liquid that is classified as a medical device. It is a hydrated polymer system (oral hydrogel) and is intended for the management of oral mucositis/stomatitis. When gently distributed within the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa. Subjects undergoing chemotherapy with radiation for the treatment of head and neck cancer are at high risk of developing oral mucositis as an adverse side-effect of cancer treatment. MuGard was previously shown to reduce the incidence and severity of mucositis in head and neck cancer patients undergoing radiation therapy when compared with data from historical control groups. The purpose of this study is to perform a direct comparison of the effectiveness of MuGard with a control group.
The purpose of this study is to test the drug RAD001 in combination with other chemotherapy drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination. The investigators will test the safety of RAD001 in combination with Carboplatin and Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin and Cetuximab will not be varied as both these drugs are considered to be part of the current standard of care for patients with your condition.
The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome
The proposed study is a first-in-human pilot of a novel anti-cancer strategy: Metnase inhibition to potentiate DNA damaging chemotherapy. The investigators will conduct serial tumor biopsies in subjects with HNSCC at three timepoints: baseline, after cisplatin, and after cisplatin-raltegravir. The investigators will investigate immunohistochemical expression changes of γH2AX, Chk2, and Annexin V, three biomarkers of DNA damage and apoptosis. The study is designed to identify an intermediate signal of the potentiation of cisplatin chemotherapy by raltegravir in HNSCC, which will justify a future phase I/II study.
The clinical hypothesis of this study is that the first-line treatment with the combination of panitumumab and paclitaxel will provide benefit for patients with metastatic or current Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Induction chemotherapy is gaining momentum in the management of locally advanced squamous cell carcinoma of the head and neck (SCCHN). The combination of docetaxel, cisplatin, and 5-FU (TPF) was superior compared with PF in a Phase III clinical trials73,74. We have completed a Phase II clinical trial that showed that docetaxel, cisplatin, and cetuximab (TPE) is highly active and well tolerated as induction chemotherapy in SCCHN (Argiris et al. ASCO 2008; A6002). Preliminary survival results are very encouraging. 39 patients were enrolled and with median follow up 26 months the 2-year PFS was 70% and the 2-year OS 84%.The combination of chemotherapy plus cetuximab is already a standard treatment in recurrent or metastatic SCCHN47. Therefore, TPE can be used as the platform for the addition of novel agents. EGFR and VEGF are among the most important and validated molecular targets in cancer therapy. The incorporation of novel targeted therapies to chemotherapy and radiotherapy is of particular interest in head and neck cancer, and may improve efficacy without significantly increasing toxicity. A Phase III trial of carboplatin/paclitaxel/bevacizumab with or without cetuximab in advanced NSCLC has been proposed by SWOG. Bevacizumab is currently being investigated in SCCHN with promising results. A Phase II study investigating the combination of pemetrexed and bevacizumab (UPCI 05-002) as well as a Phase II trial of cetuximab and bevacizumab (UPCI 05-087) in recurrent or metastatic SCCHN are ongoing at the University of Pittsburgh with encouraging results (ASCO 2008 and ASCO 2009). In this study, 32 have been already enrolled. There was only 1 patient with grade 3 hemorrhage. The objective response rate is 20%, the median PFS 2.8 months and the median OS 8.1 months. In order to further improve the efficacy of TPE and the rate of complete responses we propose to add bevacizumab to the TPE followed by XPE regimen we developed at the University of Pittsburgh. Due to non-overlapping toxicities and based on our prior experience we anticipate that the regimen will be well tolerated. Moreover, we plan to obtain tumor biopsies and blood samples in the first cycle and evaluate the modulation of biomarkers post combination therapy. Data from induction with TPE (presented at ASCO 2009) indicate the potential significance of cytokine levels in patient outcome. Also, we will evaluate the feasibility of subsequent concurrent radiation, cisplatin, cetuximab and bevacizumab. Patients with stable disease in the primary could be considered candidates to surgical resection at the discretion of their physician, if the tumor is resectable.
The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET imaging is effective as an imaging tool for the early detection of response of oncological tumors in the lungs,head and neck to chemoradiation therapy. The study will evaluate the potential of [18F]-ML-10 used in conjunction with PET imaging to distinguish early during the course of chemoradiation therapy between a tumor that responds to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction is available to the physician several weeks or months after completion of therapy, using anatomical imaging (for example Computed Tomography [CT] or Magnetic Resonance Imaging [MRI]).
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.
This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in combination with cetuximab in patients with advanced head and neck cancer.
RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease. PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.