title: A phase II study of combined administration of dacarbazine and carboplatin with home therapy of recombinant interleukin-2 and interferon-alpha 2a in patients with advanced malignant melanoma.
abstract: Chemotherapy and interleukin-2 (IL-2) and/or interferon alpha (IFN alpha) produce objective responses in a proportion of patients with advanced malignant melanoma. The duration of response to chemotherapy is usually less than 4 months, and immunotherapy has resulted in long-lasting remissions in a small number of patients with metastatic melanoma. The current study was conducted to improve the antitumor efficacy and the interactions between recombinant (r) IL-2, rIFN alpha 2a and chemotherapy. A total of 16 evaluable patients with metastatic malignant melanoma were entered into a phase-II study designed to assess the response rate and therapeutic efficacy of dacarbazine and carboplatin followed by rIL-2 and rIFN alpha 2a. Patients received 750 mg/m2 dacarbazine with 400 mg/m2 carboplatin each by intravenous bolus on days 1 and 22. Recombinant IL-2 and IFN alpha 2a were administered on an outpatient basis (home therapy) subcutaneously for 6 consecutive weeks: 4.8 x 10(6) IU/m2 rIL-2 daily, 5 days a week; 6.0 x 10(6) IU/m2 rIFN alpha 2a thrice weekly. There were responses in 6 of the 16 enrolled patients with an overall response rate of 37.5% (95% confidence interval: 14%-61%). All responding patients had partial responses. The median survival time of the responding patients was significantly better than that of patients with progressive and stable disease (P = 0.03). The median duration of response was 11 months (range 2-24 months). Responses in lung, liver, soft tissue and lymph-node sites were noted.
authors.affiliation: Department of Oncology, Tel-Aviv Sourasky Medical Centre, Israel.
authors.forename: I G
authors.initials: IG
authors.lastname: Ron
authors.forename: Y
authors.initials: Y
authors.lastname: Mordish
authors.forename: A
authors.initials: A
authors.lastname: Eisenthal
authors.forename: Y
authors.initials: Y
authors.lastname: Skornick
authors.forename: M J
authors.initials: MJ
authors.lastname: Inbar
authors.forename: S
authors.initials: S
authors.lastname: Chaitchik
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000008:administration & dosage; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins; D015996:Survival Rate
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007376:Interleukin-2; D011994:Recombinant Proteins; D003606:Dacarbazine; D016190:Carboplatin