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Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma



Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma

For Condition: angioimmunoblastic T-cell lymphoma,Cutaneous T-Cell Lymphoma,anaplastic large cell lymphoma,Hodgkin's lymphoma,Non-Hodgkin's Lymphoma,adult T-cell leukemia and lymphoma
Status: Recruiting
Sponsor(s): University of Washington , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, carboplatin, and dexamethasone with or without rituximab in treating patients who have relapsed or primaryrefractorylymphoma.
Details: OBJECTIVES: - Determine the feasibility and safety of gemcitabine, carboplatin, and dexamethasone with or without rituximab, in terms of response rate, in patients with relapsed or primary refractory lymphoid malignancy. - Determine the efficacy of these regimens in these patients. - Determine the impact of these regimens on stem cell reserve in these patients. - Determine the remission duration in patients treated with these regimens. OUTLINE: This is a pilot study. Patients are stratified according to CD20 expression (negative vs positive). - Stratum I (CD20 negative): Patients receive carboplatin IV over 30 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; and oral dexamethasone on days 1-4. - Stratum II (CD20 positive): Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8. In both strata, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study within 2-3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of relapsed or primary refractory lymphoid malignancy, including the following types: - B-cell lymphoma - T-cell lymphoma - Hodgkin’s lymphoma - No disease refractory (i.e., not responded or progressed within 6 months) to a carboplatin- or cisplatin-based regimen or a gemcitabine-based regimen - Bidimensionally measurable disease - At least 1 cm by CT scan, MRI, medical photograph (skin or oral lesion), plain x-ray, or other conventional techniques OR at least 2 cm by palpation - Bone marrow aspirate and biopsy within the past 28 days - No prior anticancer therapy during the interval between bone marrow aspirate and biopsy and study entry - No active CNS lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - SWOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin less than 2 times upper limit of normal (ULN) Renal - Creatinine less than 1.5 times ULN - Creatine clearance greater than 50 mL/min Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 6 months after study participation - HIV negative - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AjayGopal,  Study Chair,  Seattle Cancer Care Alliance

Seattle Cancer Care Alliance *Recruiting*
Seattle,  Washington,  98109
United States
Recruiting Ajay  Gopal 206-288-2037


Additional Information:
Study ID Numbers:
  CDR0000339814;  LILLY-B9E-US-X348,PSOC-2003,UW-LYM.03.01
Study Start Date: 
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072514

Other Anaplastic Large Cell Lymphoma Studies:
1. Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma

2. Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma

3. Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

4. Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

5. Reduced-Intensity Regimen Before Bone Marrow Transplantation in Treating Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma

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