Spots Global Cancer Trial Database for Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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Trial Identification

Brief Title: Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Official Title: A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Study ID: NCT00006471

Conditions

Head and Neck Cancer

Interventions

Fenretinide

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic head and neck cancer.

Detailed Description: OBJECTIVES: * Determine the response rate, time to progression, median survival, and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide. * Determine the pharmacokinetics and safety of this drug in these patients. OUTLINE: Patients receive oral fenretinide every 12 hours on days 1-7. Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response continue treatment for 1 year. PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.