A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Christos E. Emmanouilides, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000380845
NCT ID:
NCT00090909
Start Date:
June 2003
Completion Date:
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
