Bryostatin 1 in Treating Patients With Relapsed Multiple Myeloma
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 relapsed multiple myeloma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA|
|Study Start Date:||January 1997|
|Study Completion Date:||November 2000|
|Primary Completion Date:||January 1999 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 72-hour continuous infusion in patients with relapsed multiple myeloma. II. Determine the qualitative and quantitative toxic effects of bryostatin 1 in these patients. III. Determine the duration of response and survival following bryostatin 1 in these patients.
OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks until disease progression or 2 courses beyond complete remission. Response is assessed after every 4 courses. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 15-25 evaluable patients will be entered into this study over 1.25 years.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Study Chair:||Ayad M. Al-Katib, MD, FACP||Barbara Ann Karmanos Cancer Institute|