Clinical trial NCT00006473: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response rate
timeFrame: Up to 6 years
Secondary outcomes:
measure: Duration of response
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Anas Younes
role: PRINCIPAL_INVESTIGATOR
References: