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

Phase 2

Completed

• 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
• Interventions: Drug: oxaliplatin

• Registration Number: NCT00006473
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2000-11-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (oxaliplatin)	oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Response rate	Up to 6 years	Using a Simon's two-stage model.

Secondary Outcome Measures

Name	Time	Method
Duration of response	Up to 6 years	Analyzed using the Kaplan-Meier method.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States