A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck
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.
Primary Purpose: Treatment
David G. Pfister, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|