A Randomized Pre-Phase II Trial of Interleukin-2, Interleukin-12, or No Additional Therapy Following Response to Ifosfamide/Etoposide Chemotherapy for Refractory HIV-Associated Non-Hodgkin's Lymphoma
18 Years
70 Years
Both
Lymphoma
Trial Information
A Randomized Pre-Phase II Trial of Interleukin-2, Interleukin-12, or No Additional Therapy Following Response to Ifosfamide/Etoposide Chemotherapy for Refractory HIV-Associated Non-Hodgkin's Lymphoma
OBJECTIVES:
I. Determine the efficacy of interleukin-12 (IL-12) by evaluating its effect on remission
duration after response to second line chemotherapy with ifosfamide and etoposide in
patients with HIV-associated non-Hodgkin's lymphoma.
II. Determine the safety of IL-12 when administered as maintenance therapy in these
patients.
III. Evaluate overall survival of this patient population. IV. Evaluate serum and tissue
cytokine levels in these patients. V. Evaluate the effect of IL-12 on HIV viral load and on
functional T-cell assays in these patients.
VI. Evaluate the effect of IL-12 on Epstein-Barr Virus (EBV) viral load in these patients.
OUTLINE: This is an open label study.
All patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2
hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13.
Courses are repeated every 21 days. Patients who have complete or partial remission after a
minimum of 4 courses of chemotherapy receive maintenance therapy consisting of
interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and
continuing for 6 months or until disease progression. All patients also receive combination
antiretroviral therapy during study.
Patients are followed every month for one year, then every 2 months thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- HIV-infected patients with histologically or cytologically proven intermediate grade
large cell lymphoma; high grade large cell immunoblastic lymphoma; or high grade
small noncleaved cell lymphoma who have either failed to respond to or relapsed
following first line combination chemotherapy
- Bidimensionally measurable disease
- No CNS lymphoma (parenchymal brain or spinal cord tumor)
- No meningeal lymphoma
- A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ.
The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this
protocol uses the former terminology.
PATIENT CHARACTERISTICS:
- Age: 18 to 70
- Performance status: Karnofsky 60-100%
- Absolute neutrophil count at least 1,000/mm3
- Platelet count greater than 75,000/mm3
- Hematologic criteria not applicable if abnormal functions are attributable to
lymphomatous infiltration of bone marrow or liver
- Bilirubin less than 2.0 mg/dL, except in patients receiving indinavir who have
isolated hyperbilirubinemia
- Transaminases less than 5 times upper limit of normal
- Hepatic criteria not applicable if abnormal functions are attributable to
lymphomatous infiltration of bone marrow or liver
- Creatinine clearance greater than 60 mL/min
- No other prior or concurrent malignancy except carcinoma in situ of the cervix or
nonmetastatic nonmelanomatous skin cancer
- No acute active opportunistic infection requiring antibiotic treatment Patients with
Mycobacterium avium complex allowed
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior immunomodulating agents
- Concurrent filgrastim (G-CSF) allowed
- Concurrent epoetin alfa allowed
- Concurrent antibiotics may be given if clinically indicated during study
- No more than 2 prior standard treatment regimens for non-Hodgkin's lymphoma
- No concurrent systemic corticosteroids
- Concurrent topical and/or oral antifungal agents permitted
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Lawrence D. Kaplan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02276
NCT ID:
NCT00003575
Start Date:
January 1999
Completion Date:
Related Keywords:
- Lymphoma
- AIDS-related peripheral/systemic lymphoma
- AIDS-related diffuse large cell lymphoma
- AIDS-related immunoblastic large cell lymphoma
- AIDS-related small noncleaved cell lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
| San Francisco General Hospital Medical Center | San Francisco, California 94110 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| University Hospital/New Jersey Cancer Center | Newark, New Jersey 07103 |
