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
Enfermedades hemáticas y linfáticas+5
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 1999
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 40 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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 Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalCentros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 10 ubicaciones
USC/Norris Comprehensive Cancer Center
Los Angeles, United StatesAbrir USC/Norris Comprehensive Cancer Center en 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