Waldenström's Macroglobulinemia |
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Clinical Trial: Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
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
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 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:
- No other concurrent investigational drugs
- No concurrent antiretroviral therapy for HIV-positive patients
Location Information
Anas Younes, MD, Study Chair, M.D. Anderson Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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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