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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

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

Treatments: Drug: oxaliplatin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00006473

NCI-2012-02363

ID99-406

CDR0000068297 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Treatment (oxaliplatin)

Experimental group

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.

Treatment:

Drug: oxaliplatin