Brief Title
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate
Secondary Outcome
Duration of response
Condition
Angioimmunoblastic T-cell Lymphoma
Intervention
oxaliplatin
Study Arms / Comparison Groups
Treatment (oxaliplatin)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
72
Start Date
September 2000
Primary Completion Date
February 2006
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Anas Younes, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00006473
Organization ID
NCI-2012-02363
Secondary IDs
ID99-406
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Anas Younes, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
January 2013