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


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Waldenström's Macroglobulinemia


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

This study is no longer recruiting patients.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
Waldenstrom's Macroglobulinemia
adult T-cell leukemia and lymphoma
adult non-Hodgkin's lymphoma
angioimmunoblastic T-cell lymphoma
 Drug: oxaliplatin
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases;   Lymphoma;   Vascular Diseases;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Oxaliplatin in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

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:


Location Information


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

Study chairs or principal investigators

Anas Younes, MD,  Study Chair,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068297; MDA-ID-99406; NCI-1652
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 6, 2000
ClinicalTrials.gov Identifier:  NCT00006473
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 13, 2008



Page Updated: September 23, 2004
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