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Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003171
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : April 5, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Drug: bryostatin 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Clinical Evaluation of Bryostatin 1 in Patients With Myelodysplastic Syndrome
Study Start Date : May 1998
Actual Primary Completion Date : July 1999
Actual Study Completion Date : June 2003

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003171


Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
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Study Chair: Ayad M. Al-Katib, MD, FACP Barbara Ann Karmanos Cancer Institute
More Information
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Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00003171    
Other Study ID Numbers: CDR0000065975
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-D-1468
NCI-T97-0047
First Posted: July 19, 2004    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013
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:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Bryostatin 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents