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Phase II Study of Bryostatin 1 in Patients With Metastatic Colo-Rectal Adenocarcinoma
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 colorectal cancer.
OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 24 hour intravenous infusion every week for 3 weeks during a 4 week course of therapy in patients with colorectal cancer. II. Determine the response duration, time to progression, and survival time in this patient population. III. Determine the qualitative and quantitative toxic effects of bryostatin 1 on this schedule in this patient population. OUTLINE: Patients are treated with bryostatin 1 as a 24 hour continuous intravenous infusion weekly for 3 weeks followed by 1 week of rest. Courses are repeated every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients who have no toxic effects after the completion of the first course of therapy may have the dose of bryostatin 1 escalated by 1 dose level in subsequent courses. Patients are followed for response duration and time to treatment failure. PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 18 months.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Start Date
February 1, 1998
Primary Completion Date
November 1, 2000
Completion Date
June 1, 2001
Last Updated
April 5, 2013
bryostatin 1
DRUG
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
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