Spots Global Cancer Trial Database for Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome

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Trial Identification

Brief Title: Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome

Official Title: Phase II Clinical Evaluation of Bryostatin 1 in Patients With Myelodysplastic Syndrome

Study ID: NCT00003171

Conditions

Leukemia

Myelodysplastic Syndromes

Interventions

bryostatin 1

Study Description

Brief Summary: 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.

Detailed Description: 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.