Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome
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 myelodysplastic syndrome.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Clinical Evaluation of Bryostatin 1 in Patients With Myelodysplastic Syndrome|
|Study Start Date:||May 1998|
|Study Completion Date:||June 2003|
|Primary Completion Date:||July 1999 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the response rate of bryostatin 1 in patients with myelodysplastic syndrome. II. Determine the qualitative and quantitative toxic effects of bryostatin 1. III. Determine the duration of response and survival of patients receiving this therapy.
OUTLINE: This is a two stage study. Patients receive bryostatin 1 by continuous infusion over 72 hours every 14 days for 4 cycles. Responding patients may continue treatment in the absence of disease progression or unacceptable toxicity. Patients with complete response receive 2 additional cycles. Patients with no response receive 4 additional cycles. Patients are re-evaluated after every 4 cycles.
PROJECTED ACCRUAL: 14 to 27 patients will be accrued within 2 years into this 2 stage study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003171
|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|