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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006473
Enrollment
72
Registered
2003-01-27
Start date
2000-09-30
Completion date
Unknown
Last updated
2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia

Brief summary

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

Detailed description

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.

Interventions

DRUGoxaliplatin

Given IV

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Response rateUp to 6 yearsUsing a Simon's two-stage model.

Secondary

MeasureTime frameDescription
Duration of responseUp to 6 yearsAnalyzed using the Kaplan-Meier method.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026