A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study
recombinant interferon alfa
Infections par virus ADN+21
+ Maladies Hématologiques
+ Maladies hématologiques et lymphatiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1994
Date à laquelle le premier participant a commencé l'étude.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.
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.8 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.Jusqu'à 21 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: 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 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
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres 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
Via Christi Regional Medical Center
Wichita, United StatesOuvrir Via Christi Regional Medical Center dans Google MapsMBCCOP - LSU Health Sciences Center
New Orleans, United StatesTomorrows Children's Institute
Hackensack, United StatesMission Saint Joseph's Health System
Asheville, United States