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

This study has been completed.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006473
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: oxaliplatin
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Oxaliplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   September 2000

Detailed Description:

OBJECTIVES:

  • Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma.
  • 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2
  • Karnofsky 50-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin normal
  • SGOT/SGPT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent colony-stimulating factors during first course of therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Other:

  • No other concurrent investigational drugs
  • No concurrent antiretroviral therapy for HIV-positive patients
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006473

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4009

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Anas Younes, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068297, MDA-ID-99406, NCI-1652
First Received:   November 6, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006473
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia  
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent grade 3 follicular lymphoma  
recurrent adult diffuse small cleaved cell lymphoma  
recurrent adult diffuse mixed cell lymphoma  
recurrent adult diffuse large cell lymphoma  
recurrent adult immunoblastic large cell lymphoma  
recurrent adult lymphoblastic lymphoma  
recurrent adult Burkitt lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent mantle cell lymphoma
angioimmunoblastic T-cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Lymphoma, large-cell, immunoblastic
Lymphoma, B-Cell
Lymphoma, large-cell
Burkitt's lymphoma
Leukemia
Oxaliplatin
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Waldenstrom macroglobulinemia
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Leukemia-Lymphoma, Adult T-Cell
Lymphoblastic lymphoma
Mantle cell lymphoma
Recurrence
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Burkitt Lymphoma
B-cell lymphomas
Leukemia, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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