Bryostatin 1 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00003443|
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: bryostatin 1||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||May 2001|
|Actual Study Completion Date :||May 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003443
|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|