Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003171
First received: November 1, 1999
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Leukemia
Myelodysplastic Syndromes
Drug: bryostatin 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Clinical Evaluation of Bryostatin 1 in Patients With Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Study Start Date: May 1998
Study Completion Date: June 2003
Primary Completion Date: July 1999 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003171

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Ayad M. Al-Katib, MD, FACP Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00003171     History of Changes
Other Study ID Numbers: CDR0000065975, P30CA022453, WSU-D-1468, NCI-T97-0047
Study First Received: November 1, 1999
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
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

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions
Bryostatin 1
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014