Bryostatin 1 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
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 bryostatin 1 in treating patients with metastatic or recurrent head and neck cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck|
|Study Start Date:||July 1998|
|Study Completion Date:||May 2001|
|Primary Completion Date:||May 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the antitumor activity of bryostatin 1 in chemotherapy naive patients with metastatic or recurrent head and neck squamous cell carcinoma, not curable with surgery or radiation therapy. II. Evaluate the safety and toxicity of bryostatin 1 when administered in the prescribed schedule in this patient population. III. Assess cyclin dependent kinase 2 activity, protein kinase C activity, and apoptosis measurements in selected patients with tumors accessible for biopsy following bryostatin 1 therapy.
OUTLINE: Patients receive bryostatin 1 IV over 24 hours once weekly for three weeks followed by one week of rest. Treatment is continued every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients with stable disease after two courses may continue treatment or stop treatment at the discretion of the treating physician.
PROJECTED ACCRUAL: There will be 14-25 patients accrued into this study over 1-2 years.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David G. Pfister, MD||Memorial Sloan-Kettering Cancer Center|