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



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

For Condition: adult T-cell leukemia and lymphoma,angioimmunoblastic T-cell lymphoma,adult non-Hodgkin's lymphoma,Waldenstrom's Macroglobulinemia
Status: No longer recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma. - Determine the treatment-related toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive). Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A maximum of 72 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: - Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype - Indolent - Follicular small cleaved cell - Follicular mixed cell - Small lymphocytic - Mucosa-associated lymphoid tissue (MALT) - Monocytoid B-cell - Waldenstrom's macroglobulinemia - Aggressive - Follicular large cell - Diffuse large cell - Immunoblastic - Mantle cell - Ki-1+ NHL - Peripheral T-cell - Angiocentric and angioimmunoblastic - Transformed lymphoma - Bidimensionally measurable disease - No more than 3 prior treatment regimens as follows: - Primary radiotherapy is 1 regimen - Combined therapy with radiotherapy and chemotherapy is 1 regimen - Alternating therapy is 1 regimen - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 - Karnofsky 50-100% Life expectancy: - Not specified Hematopoietic: - WBC count at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - No neuropathy greater than grade 1 - No history of allergy to platinum compounds or antiemetics - No uncontrolled illness - No active infection - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent colony-stimulating factors during first course of therapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy Other: - No other concurrent investigational drugs - No concurrent antiretroviral therapy for HIV-positive patients
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AnasYounes,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4009
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068297;  NCI-1652,MDA-ID-99406
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006473

Other Angioimmunoblastic T-Cell Lymphoma Studies:
1. Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma

2. Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma

3. Filgrastim and Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma

4. Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory 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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Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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