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
Néoplasmes+9
+ Néoplasmes par type histologique
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 1995
Date à laquelle le premier participant a commencé l'étude.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.
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.90 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.De 18 à 70 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 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
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 24 sites
Landeskrankenanstalten - Salzburg
Salzburg, AustriaOuvrir Landeskrankenanstalten - Salzburg dans Google MapsHopital Universitaire Erasme
Brussels, BelgiumInstitut Jules Bordet
Brussels (Bruxelles), BelgiumUniversitair Ziekenhuis Antwerpen
Edegem, Belgium