Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00003171|
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : April 5, 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 myelodysplastic syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: bryostatin 1||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Clinical Evaluation of Bryostatin 1 in Patients With Myelodysplastic Syndrome|
|Study Start Date :||May 1998|
|Actual Primary Completion Date :||July 1999|
|Actual Study Completion Date :||June 2003|
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): 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|