A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma
Data Collection
Hodgkin Disease+5
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: June 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1 patient to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location