A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study
recombinant interferon alfa
Infecciones por virus ADN+17
+ Enfermedades Hematológicas
+ Enfermedades hemáticas y linfáticas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1994
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa. Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients. OUTLINE: Induction: Patients receive interferon alfa subcutaneously (SC) daily on days 1-14. Patients with advanced stage III or IV undifferentiated lymphomas or B-cell acute lymphoblastic leukemia also receive hydrocortisone intrathecally (IT) combined with cytarabine IT on day 14. Maintenance: Patients with stable or responding disease after completion of induction receive interferon alfa SC 3 times a week beginning on week 1. Treatment continues for a minimum of 4-12 weeks in the absence of disease progression or unacceptable toxicity. Patients who received IT therapy during induction receive the same IT therapy at 4, 8, and 12 weeks and then every 8 weeks thereafter. Patients are followed every 6 months for 4 years and then annually for survival until entry on another POG protocol. PROJECTED ACCRUAL: A total of 14-30 evaluable patients will be accrued for this study within 4.2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 8 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.Hasta 21 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: Histologically proven malignancy diagnosed at any time following confirmation of HIV-positivity, including the following: Leukemia Non-Hodgkin's lymphoma CNS lymphoma Other solid tumors Measurable disease Concurrent registration on protocol POG-9182 required Confirmed HIV-positive by POG-9182 criteria Required biology studies completed PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: More than 4 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 (unless bone marrow involvement present) Hepatic: See Disease Characteristics Bilirubin less than 1.5 times normal SGPT and SGOT less than 2 times normal (may discuss with Study Coordinator) Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Adequate cardiac function by echocardiogram/MUGA scan Other: Chronically infected patients must be stable enough to meet life expectancy requirement PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon for cancer Prior interferon alfa for viral infections (i.e., hepatitis) must be discussed with Study Coordinator Chemotherapy: At least 1 week since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 1 week since prior radiotherapy Surgery: Not specified Other: Prior antiretroviral therapy allowed At least 1 week since prior acute treatment for any serious or life-threatening infection No concurrent local treatment unless discussed with the Study Coordinator No concurrent acute treatment for any serious or life-threatening infection Concurrent antiretroviral therapy allowed
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
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros 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
Via Christi Regional Medical Center
Wichita, United StatesAbrir Via Christi Regional Medical Center en Google MapsMBCCOP - LSU Health Sciences Center
New Orleans, United StatesTomorrows Children's Institute
Hackensack, United StatesMission Saint Joseph's Health System
Asheville, United States