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Completed

NCT Number: NCT00006473

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

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

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Key information

Conditions

Angioimmunoblastic T-cell Lymphoma Blood Protein Disorders Burkitt Lymphoma Cardiovascular Diseases Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nodal Marginal Zone B-cell Lymphoma Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-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 Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia Waldenström Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin

Drug

Given IV

Other names: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Primary outcomes

  1. Response rate

    Time frame: Up to 6 years

    Using a Simon's two-stage model.

Secondary outcomes

  1. Duration of response

    Time frame: Up to 6 years

    Analyzed using the Kaplan-Meier method.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma

Important dates

Study start
2000
Primary completion
2006
First posted
Jan 27, 2003
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.