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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00090909

Enrollment

Registered

2004-09-08

Start date

2003-06-30

Completion date

Unknown

Last updated

2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

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.

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.

Interventions

DRUGcisplatin

DRUGdexamethasone

DRUGgemcitabine hydrochloride

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026