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Gemcitabine, Cisplatin, and Dexamethasone in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00090909
Collaborator
National Cancer Institute (NCI) (NIH)
1
Enrollment
1
Location

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and dexamethasone, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with dexamethasone works in treating patients with relapsed or refractory Hodgkin's lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the response rate and maximum response in patients with relapsed or refractory Hodgkin's lymphoma treated with gemcitabine, cisplatin, and dexamethasone.

  • Determine time to progression in patients treated with this regimen who are not undergoing stem cell transplantation.

  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gemcitabine IV over 1 hour on days 1 and 8, cisplatin IV over 3 hours on day 1, and oral dexamethasone twice daily on days 1-4. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed until disease progression.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Mar 1, 2005

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 Hodgkin's lymphoma

    • Measurable disease by radiological or clinical findings

    • Failed at least 1, but no more than 2, prior standard chemotherapy regimens

    • High-dose chemotherapy administered after a chemotherapy course is considered 2 courses

    • No evidence of CNS disease

    • No history of myelodysplastic syndromes

    PATIENT CHARACTERISTICS:

    Age

    • Over 18

    Performance status

    • ECOG 0-2

    Life expectancy

    • Not specified

    Hematopoietic

    • WBC > 2,000/mm^3

    • Absolute neutrophil count > 1,500/mm^3

    • Platelet count > 75,000/mm^3

    • Hemoglobin > 8.0 g/dL

    Hepatic

    • Bilirubin < 2 times upper limit of normal (ULN)

    • AST and ALT < 5 times ULN

    Renal

    • Creatinine < 1.5 times ULN

    Other

    • Not pregnant or nursing

    • Fertile patients must use effective contraception during and for 3 months after study participation

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • Not specified

    Chemotherapy

    • See Disease Characteristics

    • No prior gemcitabine

    • More than 6 months since prior high-dose chemotherapy

    Endocrine therapy

    • Not specified

    Radiotherapy

    • Not specified

    Surgery

    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jonsson Comprehensive Cancer Center at UCLA Los Angeles California United States 90095-1678

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Christos E. Emmanouilides, MD, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00090909
    Other Study ID Numbers:
    • CDR0000380845
    • UCLA-030402301
    • LILLY-B9E-US-X394
    First Posted:
    Sep 8, 2004
    Last Update Posted:
    Jan 8, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by , ,
    recurrent adult Hodgkin lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Gemcitabine
    Dexamethasone

    Study Results

    No Results Posted as of Jan 8, 2013