- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003936
Bryostatin 1 in Treating Patients With Recurrent or Refractory Hodgkin's Disease
Phase II Clinical Evaluation of Bryostatin 1 in Patients With Hodgkin's Disease
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 who have recurrent or refractory Hodgkin's disease.
Study Overview
Detailed Description
OBJECTIVES: I. Determine the response rate in patients with recurrent or refractory Hodgkin's disease treated with bryostatin 1. II. Determine qualitative and quantitative toxicities of bryostatin 1 in these patients. III. Determine duration of response and survival in these patients.
OUTLINE: Patients receive bryostatin 1 by continuous IV infusion over 72 hours. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity for at least 4 courses. Patients who achieve complete response (CR) are treated with 4 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 2 years.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Diagnosis of recurrent or refractory Hodgkin's disease Measurable disease Must have failed the following regimens: Mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) AND Doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) May have undergone either bone marrow or peripheral blood stem cell transplant Must not be eligible for standard treatment (high intensity therapy with peripheral blood stem cell or bone marrow transplant) or higher priority protocol
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count (ANC) at least 1,000/mm3 (at least 500/mm3 if extensive bone marrow involvement) Platelets at least 75,000/mm3 (at least 50,000/mm3 if extensive bone marrow involvement) Hepatic: Bilirubin less than 1.5 mg/dL ALT and AST less than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (8 weeks since mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: David S. Eilender, MD, Barbara Ann Karmanos Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067128
- P30CA022453 (U.S. NIH Grant/Contract)
- WSU-C-1902
- NCI-T97-0120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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