A Phase 2 interventional study of oxaliplatin in Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue and Nodal Marginal Zone B-cell Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-23.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 72 is above the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype
Indolent
Aggressive
No more than 3 prior treatment regimens as follows:
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.
Drug: oxaliplatin
Given IV
Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Response rate
Using a Simon's two-stage model.
Time frame: Up to 6 years
Duration of response
Analyzed using the Kaplan-Meier method.
Time frame: Up to 6 years
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)