Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00003171|
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : April 5, 2013
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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|
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 Type :||Interventional (Clinical Trial)|
|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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
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
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Study Chair:||Ayad M. Al-Katib, MD, FACP||Barbara Ann Karmanos Cancer Institute|
|Responsible Party:||Barbara Ann Karmanos Cancer Institute|
|Other Study ID Numbers:||
P30CA022453 ( U.S. NIH Grant/Contract )
|First Posted:||July 19, 2004 Key Record Dates|
|Last Update Posted:||April 5, 2013|
|Last Verified:||April 2013|
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
Bone Marrow Diseases
Physiological Effects of Drugs