Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation...
Head and Neck CancerOral MucositisThe purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.
Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer
Cancer of the PharynxCancer of the Larynx3 moreThere is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal complications. Therefore, less toxic and more effective reirradiation regimens are urgently needed. There are extensive data from animal studies and preliminary human studies showing that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans and appear to have less severe toxicity than conventional chemotherapeutic agents.
Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With...
Head and Neck NeoplasmsSkin NeoplasmsThis study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or advanced/metastatic, cutaneous or sub-cutaneous malignancies.
Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck
CarcinomaAdenoid Cystic1 moreThe purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an oncologic agent for adenoid cystic cancers of the head and neck. Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their medical oncologist as clinically indicated while taking this medication. Subjects would be evaluated for quality of life issues utilizing the EORTC QLQ-C30 2-page questionnaire. Subjects would also be evaluated clinically by the oncologist to determine if the NFV was having an anti-neoplastic effect. The study remains unfunded. Therefore, potential subjects must be willing to provide self-travel to study site. This study requires a screening visit, initial study visit, and monthly follow-up. Subjects are not reimbursed for time, travel, or physician costs.
Study of HF10 in Patients With Refractory Head and Neck Cancer or Solid Tumors With Cutaneous and/or...
Refractory Head and Neck CancerSquamous Cell Carcinoma3 moreThe purpose of this study is to determine whether HF10 is safe and effective in the treatment of head and neck cancer or solid tumors with cutaneous and/or superficial lesions.
A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)...
Head and Neck NeoplasmsLung Neoplasms2 moreBackground: Two experimental drugs, FdCyd (also called 5-fluoro-2'-deoxcytidine), and THU (also called tetrahydrouridine), are undergoing trials to test their effectiveness in treating cancer that has not responded to standard therapies. FdCyd is thought to work by changing how genes work in cancer cells. THU does not have any anticancer effects on its own, but it helps keep the other drug, FdCyd, from being broken down by the body. These drugs are being tested in several separate clinical trials. Objectives: To determine if FdCyd and THU can work together to control tumor growth. To evaluate the safety and tolerability of FdCyd and THU when given together. Eligibility: - Individuals 18 years of age and older who have advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer that has progressed after receiving standard treatment or for which no effective therapy exists. Design: The drugs are given over 28-day periods called cycles. FdCyd and THU are given through a vein for about 3 hours each day on days 1, 5 and 8, 12 of each cycle. Clinical Center visits: FdCyd and THU will be given through a vein on days 1, 5 and 8, 12 of each cycle. During the Clinical Center visits, researchers will perform study tests and procedures to see how the study drugs are affecting the body. Patients will undergo a number of tests and procedures during the treatment cycle, including physical examinations, blood and urine samples for standard tests, imaging studies (ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) scans) to evaluate tumor growth, and blood and urine samples to evaluate the amount of FdCyd and THU in the body and the body's response to the drugs. Patients may continue to receive FdCyd and THU if their cancer does not grow, if they do not have too many side effects, and if they are willing to do so.
Vaccine Therapy in Treating Patients With Head and Neck Cancer
Head and Neck CancerRATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase I trial is studying the side effects of vaccine therapy in treating patients with head and neck cancer.
Comparison of Biomarker Modulation by Inhibition of EGFR and/or SRC Family
Head and Neck CancerNon Small Cell Lung CancerThe central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers.
Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer
Head and Neck CancerPrimary Objective: To determine the maximum tolerated doses (MTDs) of pemetrexed when given with dexamethasone. (Please note: One of the three treatment groups will not receive dexamethasone) Secondary Objectives: To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia > 7 days duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4 non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase toxicity. To determine objective response rate, as defined as complete response (CR) or partial response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.
Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage...
Head and Neck CancerRATIONALE: Drugs used in chemotherapy, such as 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 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 head and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cisplatin and bevacizumab together with intensity-modulated radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and bevacizumab together with intensity-modulated radiation therapy works in treating patients with stage III or stage IV head and neck cancer.