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Bryostatin 1 in Treating Patients With Recurrent or Refractory Hodgkin's Disease

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00003936
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
60
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 who have recurrent or refractory Hodgkin's disease.

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

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Clinical Evaluation of Bryostatin 1 in Patients With Hodgkin's Disease
Study Start Date :
Jun 1, 1999
Actual Primary Completion Date :
Jun 1, 2004
Actual Study Completion Date :
Jun 1, 2004

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: 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

    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: David S. Eilender, MD, 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:
    NCT00003936
    Other Study ID Numbers:
    • CDR0000067128
    • P30CA022453
    • WSU-C-1902
    • NCI-T97-0120
    First Posted:
    Jul 26, 2004
    Last Update Posted:
    Apr 11, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by Barbara Ann Karmanos Cancer Institute
    recurrent adult Hodgkin lymphoma
    Additional relevant MeSH terms:
    Hodgkin Disease
    Bryostatin 1

    Study Results

    No Results Posted as of Apr 11, 2014