NCT00003171

Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	bryostatin 1

Timeline

• Start date: 1998-05-01
• Primary completion: 1999-07-01
• Completion: 2003-06-01
• First posted: 2004-07-19
• Last updated: 2013-04-05

Locations

1 site across 1 country: United States