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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Using a Simon's two-stage model.

Outcome Time Frame:

Up to 6 years

Safety Issue:

No

Principal Investigator

Anas Younes

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02363

NCT ID:

NCT00006473

Start Date:

September 2000

Completion Date:

Related Keywords:

  • 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
  • Burkitt Lymphoma
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030