Active clinical trials for "Head and Neck Neoplasms"

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.

Presently, there is no effective treatment for patients with advanced head and neck cancer (AHNC) that failed to respond to the standard therapy (radiation, chemotherapy and surgery) in the US. These patients are deemed incurable AHNC. In the European Union (EU), interstitial photodynamic therapy (I-PDT) with Temoporfin is approved for the treatment of patients with incurable AHNC. Well designed EU studies have shown that I-PDT with Temoporfin can provide worthwhile palliation by reducing tumor size, bleeding and pain in 53% - 60% of patients with incurable AHNC. This is a significantly higher rate in comparison to the reported response rate of palliative chemotherapy (6-30%). However, the EU studies did not correlate quantitative tumor response with clinical outcome. In addition, quality of life (QoL) improvements associated with I-PDT of AHNC using Temoporfin were also not evaluated. The objective of this study is to quantify the tumor response and patient's QoL to I-PDT with Temoporfin. Successfully meeting this objective will give us the tools the investigators need to design larger studies to significantly improve the management and QoL of patients with AHNC.

The purpose of this study is to investigate the safety of zalutumumab in combination with radiotherapy as the treatment of patients with head and neck cancer who are not eligible for platinum based chemotherapy.

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without vandetanib in treating patients with head and neck cancer. PURPOSE: This randomized phase II trial is studying giving chemotherapy together with radiation therapy to see how well it works compared with giving chemotherapy and radiation therapy together with vandetanib in treating patients with high-risk stage III or stage IV head and neck cancer.

RATIONALE: Drugs used in chemotherapy, such as docetaxel, 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 combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known whether giving combination chemotherapy together with radiation therapy is more effective than giving cisplatin together with radiation therapy in treating cancer of the oropharynx. PURPOSE: This randomized phase III trial is studying combination chemotherapy and radiation therapy to see how well they work compared to cisplatin and radiation therapy in treating patients with stage III or stage IV cancer of the oropharynx.

Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5-fluorouracil (5-FU) and radiation in the treatment of rectal cancer. The trial showed a combined preoperative chemoradiotherapy and Oxaliplatin-containing regimen is well tolerated with no increase surgical toxicity. The good response rate observed warrants its use in further clinical trials. The combination of oxaliplatin, 5-FU, and radiation also have been used in a Phase I/II trial in esophageal cancer. In this particular trial, eligibility included therapeutically naïve esophageal cancer subjects with clinical disease stages II to IV. Initial doses and schedules for cycle 1 consisted of Oxaliplatin 85 mg/m2 on days 1, 15, and 29; continuous infusion of 5-FU 180 mg/m2 for 24 hours for 35 days; and radiation therapy (RT) 1.8 Gy in 28 fractions starting on day 8. At completion of cycle 1, eligible subjects could undergo an operation or begin cycle 2 without RT. Postoperative subjects were eligible for cycle 2. Stage IV subjects were allowed three cycles in the absence of disease progression. 38 subjects were treated (22 stage IV, 16 stage II-III). 38 eligible subjects received therapy: 22 non-invasively staged as IV and 16 non-invasively staged as IV and 16 non-invasively staged as II and III. 36 subjects completed cycle 1, 29 subjects started cycle 2, and 24 subjects completed cycle 2. The combined-modality therapy was well tolerated, but dose limiting toxicity (DLT) prevented Oxaliplatin and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3 and two grade 4 clinical toxicities were noted in eight subjects. After cycle 1, 29 subjects (81%) had no cancer in the esophageal mucosa. 13 subjects underwent an operation with intent to resect the esophagus and 5 subjects (38%) exhibited pathologic complete responses. There was no surgical mortality. Only 1 subject developed post-operative tracheoesphageal fistula. The results of these trials described above indicated that combination of oxaliplatin and radiation is safe and efficacious and dose not compromise surgical wound healing, repair and clinical outcome.

The purpose of this study is to find out whether adding ZD1839 to standard treatment (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than cisplatin and radiation alone.

The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the anterior oral cavity, soft palate, or tonsil.

This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat. PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.