- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002907
Bryostatin 1 in Treating Patients With Relapsed Multiple Myeloma
PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA
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 relapsed multiple myeloma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 72-hour continuous infusion in patients with relapsed multiple myeloma. II. Determine the qualitative and quantitative toxic effects of bryostatin 1 in these patients. III. Determine the duration of response and survival following bryostatin 1 in these patients.
OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks until disease progression or 2 courses beyond complete remission. Response is assessed after every 4 courses. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 15-25 evaluable patients will be entered into this study over 1.25 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: Multiple myeloma of any stage that has failed 1 or 2 prior regimens (chemotherapy, biologic therapy, or both, or bone marrow transplantation) Evidence of disease progression required Ineligible for known treatment of higher potential efficacy One of the following protein criteria required: Quantifiable M-components of IgG, IgA, IgD, or IgE Urinary kappa or lambda light chain (Bence-Jones protein) excretion Re-treatment on this protocol allowed if disease relapsed after a complete remission
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 50,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Transaminases less than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of impaired cardiac status, e.g.: Severe coronary artery disease Cardiomyopathy Congestive heart failure Arrhythmia Other: No known AIDS or HIV infection No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix No pregnant or nursing women Effective contraception required of fertile patients during and for 2 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy (8 weeks since mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since radiotherapy and recovered Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
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
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Bryostatin 1
Other Study ID Numbers
- CDR0000065272
- P30CA022453 (U.S. NIH Grant/Contract)
- WSU-C-1257
- WSU-D-1257
- NCI-T95-0062D
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.
Clinical Trials on Multiple Myeloma and Plasma Cell Neoplasm
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The Cleveland ClinicWithdrawnStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Plasma Cell NeoplasmUnited States
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OncotherapeuticsWithdrawnStage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Plasma Cell NeoplasmUnited States
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National Cancer Institute (NCI)CompletedStage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Plasma Cell NeoplasmUnited States
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Medical Research CouncilUnknownMultiple Myeloma and Plasma Cell NeoplasmUnited Kingdom
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LifeTime PharmaceuticalsUnknownMultiple Myeloma and Plasma Cell Neoplasm | Precancerous ConditionUnited States
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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Jonsson Comprehensive Cancer CenterMillennium Pharmaceuticals, Inc.CompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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University of Maryland, BaltimoreCompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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Masonic Cancer Center, University of MinnesotaTerminatedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)TerminatedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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Icahn School of Medicine at Mount SinaiNational Cancer Institute (NCI)CompletedCervical CancerUnited States
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Cancer Research UKCompleted
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedLymphomaUnited States
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National Cancer Institute (NCI)Completed
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