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Bryostatin 1 in Treating Patients With Relapsed Multiple Myeloma

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00002907
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
46
Duration (Months)

Study Details

Study Description

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 relapsed multiple myeloma.

Condition or Disease Intervention/Treatment Phase
  • Drug: bryostatin 1
 Phase 2

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA
Study Start Date :
Jan 1, 1997
Actual Primary Completion Date :
Jan 1, 1999
Actual Study Completion Date :
Nov 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201

    Sponsors and Collaborators

    • Barbara Ann Karmanos Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Ayad M. Al-Katib, MD, FACP, Barbara Ann Karmanos Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Barbara Ann Karmanos Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00002907
    Other Study ID Numbers:
    • CDR0000065272
    • P30CA022453
    • WSU-C-1257
    • WSU-D-1257
    • NCI-T95-0062D
    First Posted:
    Jul 19, 2004
    Last Update Posted:
    Apr 5, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Barbara Ann Karmanos Cancer Institute
    refractory multiple myeloma
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Plasmacytoma
    Bryostatin 1

    Study Results

    No Results Posted as of Apr 5, 2013