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

Lymphoma Clinical Trial

Official title:

A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090909
• Other study ID #: CDR0000380845
• Secondary ID: UCLA-030402301LI
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2004
• Last updated: January 7, 2013
• Start date: June 2003

Study information

• Verified date: January 2013
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• cisplatin

• dexamethasone

• gemcitabine hydrochloride

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,