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
Maladies hématologiques et lymphatiques+5
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.40 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 70 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalCentres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 10 sites
USC/Norris Comprehensive Cancer Center
Los Angeles, United StatesOuvrir USC/Norris Comprehensive Cancer Center dans 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