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
filgrastim
+ recombinant interleukin-12
+ etoposide
Hemic and Lymphatic Diseases+5
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: January 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
USC/Norris Comprehensive Cancer Center
Los Angeles, United StatesOpen USC/Norris Comprehensive Cancer Center in Google MapsSan Francisco General Hospital Medical Center
San Francisco, United StatesSylvester Cancer Center, University of Miami
Miami, United StatesRobert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, United States