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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Jonsson Comprehensive Cancer Center Identifier:
First received: September 7, 2004
Last updated: January 7, 2013
Last verified: January 2013

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 Intervention Phase
Drug: cisplatin
Drug: dexamethasone
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma

Resource links provided by NLM:

Further study details as provided by Jonsson Comprehensive Cancer Center:

Enrollment: 1
Study Start Date: June 2003
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC > 2,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 75,000/mm^3
  • Hemoglobin > 8.0 g/dL


  • Bilirubin < 2 times upper limit of normal (ULN)
  • AST and ALT < 5 times ULN


  • Creatinine < 1.5 times ULN


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study participation


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No prior gemcitabine
  • More than 6 months since prior high-dose chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
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Please refer to this study by its identifier: NCT00090909

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1678
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
  More Information Identifier: NCT00090909     History of Changes
Other Study ID Numbers: CDR0000380845
Study First Received: September 7, 2004
Last Updated: January 7, 2013

Keywords provided by Jonsson Comprehensive Cancer Center:
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids processed this record on April 28, 2017