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

NCT ID: NCT00006473

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (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.

Group Type EXPERIMENTAL

oxaliplatin

Intervention Type DRUG

Given IV

Interventions

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oxaliplatin

Given IV

Intervention Type DRUG

Other Intervention Names

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1-OHP Dacotin Dacplat Eloxatin L-OHP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anas Younes

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ID99-406

Identifier Type: -

Identifier Source: secondary_id

CDR0000068297

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02363

Identifier Type: -

Identifier Source: org_study_id

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