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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00090909
First received: September 7, 2004
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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
Lymphoma
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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090909

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1678
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00090909     History of Changes
Other Study ID Numbers: CDR0000380845, UCLA-030402301, LILLY-B9E-US-X394
Study First Received: September 7, 2004
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Cisplatin
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014