TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL
aldesleukin
+ recombinant interferon alfa
+ cisplatin
Neoplasias+5
+ Neoplasias por tipo histológico
+ Neoplasias por Sitio
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 1995
Fecha en la que se inscribió al primer participante.OBJECTIVES: Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2. Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms. Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses. Patients are followed every 2 months for 6 months, then every 3 months thereafter. PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 90 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: Histologically confirmed melanoma that is metastatic and unresectable Measurable, progressive disease (by physical exam and/or noninvasive imaging) No prior irradiation of indicator lesions No CNS metastases (confirmed by CT or MRI) PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: Karnofsky 60-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 2,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: No serious hepatic disease Renal: Creatinine no greater than 1.65 mg/dL No serious renal disease Cardiovascular: No serious cardiac disease Pulmonary: No serious pulmonary disease Other: No organ allograft No autoimmune disease No uncontrolled infection No active peptic ulcer No hyper or hypothyroidism No requirement for corticosteroids No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy with interleukin-2 No prior interferon alfa in combination with cisplatin or dacarbazine Chemotherapy: No prior chemotherapy with cisplatin in combination with dacarbazine More than 3 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified
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 24 ubicaciones
Landeskrankenanstalten - Salzburg
Salzburg, AustriaAbrir Landeskrankenanstalten - Salzburg en Google MapsHopital Universitaire Erasme
Brussels, BelgiumInstitut Jules Bordet
Brussels (Bruxelles), BelgiumUniversitair Ziekenhuis Antwerpen
Edegem, Belgium