Phase II Clinical Evaluation of Bryostatin 1 in Patients With Myelodysplastic Syndrome
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.
Primary Purpose: Treatment
Ayad M. Al-Katib, MD, FACP
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|