Gemcitabine, Cisplatin, and Dexamethasone in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
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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 |
| Enrollment: | 1 |
| Study Start Date: | June 2003 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
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 |
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| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1678 | |
| 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 Physiological Effects of Drugs Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents 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 May 16, 2013