- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006473
Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma
Study Overview
Status
Conditions
- 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 Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Waldenström Macroglobulinemia
- Angioimmunoblastic T-cell Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Small Lymphocytic Lymphoma
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (oxaliplatin)
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.
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Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: Up to 6 years
|
Using a Simon's two-stage model.
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Up to 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response
Time Frame: Up to 6 years
|
Analyzed using the Kaplan-Meier method.
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Up to 6 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anas Younes, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- DNA Virus Infections
- Tumor Virus Infections
- Neoplasms, Plasma Cell
- Leukemia, Lymphoid
- Leukemia
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Leukemia, B-Cell
- Lymphadenopathy
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Recurrence
- Lymphoma, Non-Hodgkin
- Burkitt Lymphoma
- Lymphoma, Mantle-Cell
- Lymphoma, B-Cell, Marginal Zone
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, Large-Cell, Immunoblastic
- Plasmablastic Lymphoma
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Immunoblastic Lymphadenopathy
- Antineoplastic Agents
- Oxaliplatin
Other Study ID Numbers
- NCI-2012-02363
- ID99-406
- CDR0000068297 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
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Yazeed SawalhaWithdrawnRecurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Grade 3a Follicular Lymphoma | Refractory Grade 1 Follicular... and other conditions
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