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

Phase 2
18 Years
Not Enrolling
Leukemia, Myelodysplastic Syndromes

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically diagnosed refractory anemia, refractory anemia
with excess blasts, refractory anemia with excess blasts in transformation, refractory
anemia with ringed sideroblasts, or chronic myelomonocytic leukemia with significant
cytopenias of at least 4 weeks duration No more than 1 prior treatment for disease Not
eligible for allogeneic bone marrow transplantation if less than 60 years of age

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 12 weeks Hematopoietic: Hematocrit less than 26% (or requiring transfusion) for
at least 4 weeks Absolute neutrophil count less than 1000/mm3 for at least 4 weeks
Platelet count less than 50/mm3 for at least 4 weeks Hepatic: Bilirubin less than 1.5
mg/dL Transaminase less than 2.5 times upper limit of normal Renal: Creatinine less than
1.5 mg/dL Creatinine clearance of at least 60 mL/min Other: Not pregnant or lactating
Fertile patients must use effective contraception while on study and for 100 days
afterwards No uncontrolled or life-threatening infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent
treatment with growth factors Chemotherapy: At least 4 weeks since prior chemotherapy (8
weeks for mitomycin or nitrosourea) and recovered Endocrine therapy: No concurrent use of
steroids Radiotherapy: At least 4 weeks since prior radiation therapy and recovered
Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ayad M. Al-Katib, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

May 1998

Completion Date:

June 2003

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201