title: A phase II study of sequential recombinant interleukin-2 followed by dacarbazine in metastatic melanoma.
abstract: 16 patients with disseminated malignant melanoma (1 with primary ocular melanoma) entered a multicentre phase II study of recombinant interleukin-2, (rIL-2) given by continuous intravenous infusion on days 1-5 at 18 x 10(6) IU/m2 per day, followed by dacarbazine 850 mg/m2 on day 8. After a 2 week rest, a second course was given. In the absence of disease progression, monthly maintenance cycles were given for up to four cycles. 16 patients received one cycle, 14 received two and 6 patients three or more. All 16 patients are evaluable for toxicity and 15 for response. 2 patients responded (13%). 1 patient with lung and pleural metastases achieved partial remission after two cycles and went off treatment after six cycles. 3 months later a complete response was noted lasting 396+ days. A second patient with lung metastases had a partial response lasting 153 days. 3 patients (20%) had stable disease. Mean rebound lymphocytosis (24-48 h after the end of rIL-2 therapy), cell count 4.9 x 10(9)/l (2.6-8.8 x 10(9)/l) was within the expected limits. Other toxicity was as expected. Thus sequential treatment with rIL-2 and dacarbazine is feasible but synergy did not occur.
authors.affiliation: Department of Oncology/Hematology, Medical University Clinic, Hamburg, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Fiedler
authors.forename: C
authors.initials: C
authors.lastname: Jasmin
authors.forename: P H
authors.initials: PH
authors.lastname: De Mulder
authors.forename: S
authors.initials: S
authors.lastname: Pyrhönen
authors.forename: P A
authors.initials: PA
authors.lastname: Palmer
authors.forename: C R
authors.initials: CR
authors.lastname: Franks
authors.forename: R
authors.initials: R
authors.lastname: Oskam
authors.forename: D K
authors.initials: DK
authors.lastname: Hossfeld
mesh_terms: D000328:Adult; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000556:secondary* / Q000628:therapy*; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins; D003606:Dacarbazine