Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2
Recombinant Interferon Alfa (IFN-A)
+ Recombinant Interferon Alfa (IFN-A)
+ Aldesleukin (IL-2)
Neoplasias+5
+ Neoplasias por tipo histológico
+ Neoplasias por Sitio
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 1995
Fecha en la que se inscribió al primer participante.OBJECTIVES: Compare the efficacy of postoperative adjuvant therapy with interferon alfa-2b (IFN-A) administered subcutaneously with or without IV induction vs concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A and IL-2 and in melanoma patients with regional lymph node metastases that have been surgically resected. Determine the relative toxic effects associated with adjuvant therapy with IFN-A and concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A, and IL-2 and their effect on the quality of life. Determine the prognostic value of detection of melanoma cells in the peripheral blood using RT/PCR for tyrosinase mRNA. OUTLINE: This is a randomized study. All patients are stratified according to prognostic factors. Patients are randomly allocated to 1 of 2 treatment options. Treatment 1 uses interferon alfa-2b (IFN-A) therapy, and treatment 2 includes adjuvant biochemotherapy. Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules. Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks. Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks. Adjuvant biochemotherapy begins immediately after registration on the study. Cisplatin is given IV on days 1-4; vinblastine is given IVPB on days 1-4; dacarbazine (DTIC) is given IVPB on day 1; IFN-A is given subcutaneously on days 1-5; IL-2 is given by continuous infusion for a total of 96 hours on days 1-4. Each course of therapy is repeated every 21 days for 4 courses. Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy. PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 140 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 10 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: Histologically diagnosed malignant melanoma with regional lymph node metastases Undergone complete lymph node dissection and free of any residual tumor No greater than 90 days from diagnosis of regional lymph nodes metastases No distant or resected in-transit metastases PATIENT CHARACTERISTICS: Age: 10 to 66 66 to 70 if in excellent physical condition Performance status: 0-2 Life expectancy: At least 12 months Hematopoietic: Hemoglobin greater than 10 g/dL WBC greater than 3,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin no greater than 1.2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: No serious intercurrent illness that would compromise tolerance of therapy and long term survival Must be able to participate in follow up for minimum of 5 years No second malignancy except: In situ cervical cancer Basal or squamous skin cancer Must be able to physically and emotionally tolerate biochemotherapy No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance, congestive heart failure, coronary bypass, or impaired cardiac ejection fraction PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy with interferon or IL-2 No concurrent immunomodulators Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: Prior adjuvant local radiotherapy allowed for head and neck Surgery: No greater than 8 weeks after definitive surgery for lymph node metastases Other: No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase inhibitors
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
ExperimentalObjetivos del Estudio
Objetivos Primarios
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 una ubicación
University of Texas - MD Anderson Cancer Center
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