Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma
Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
OBJECTIVES: I. Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma. II. 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.
Duration of response
Angioimmunoblastic T-cell Lymphoma
Study Arms / Comparison Groups
Description: 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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - 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 - Performance status - ECOG 0-2 - Performance status - Karnofsky 50-100% - 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 - Bilirubin normal - SGOT/SGPT no greater than 2.5 times upper limit of normal - Creatinine normal - Creatinine clearance at least 60 mL/min - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - 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 - No concurrent colony-stimulating factors during first course of therapy - At least 4 weeks since prior chemotherapy - At least 4 weeks since prior radiotherapy - No other concurrent investigational drugs - No concurrent antiretroviral therapy for HIV-positive patients
18 Years - N/A
Accepts Healthy Volunteers
Anas Younes, ,
National Cancer Institute (NCI)
Anas Younes, Principal Investigator, M.D. Anderson Cancer Center