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

Primary Purpose

Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioimmunoblastic T-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (oxaliplatin)

Arm 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.

Outcomes

Primary Outcome Measures

Response rate
Using a Simon's two-stage model.

Secondary Outcome Measures

Duration of response
Analyzed using the Kaplan-Meier method.

Full Information

First Posted
November 6, 2000
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006473
Brief Title
Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title
A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (oxaliplatin)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Response rate
Description
Using a Simon's two-stage model.
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Duration of response
Description
Analyzed using the Kaplan-Meier method.
Time Frame
Up to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Younes
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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