title: Phase II study of AMSA alone and in combination with DTIC in patients with metastatic melanoma.
abstract: A randomized phase II study of AMSA (amsacrine) alone and AMSA combined with DTIC (dacarbazine) was carried out in 31 and 39 patients with metastatic melanoma respectively. AMSA was used at a starting dose of 40 mg/m2/day X 3 days with escalation to 50-60 mg/m2/day X 3 days in 8 pts. For AMSA + DTIC the starting dose was: AMSA 30 mg/m2/day X 3 days; DTIC, 800 mg/m2 X 1 day. Additionally, seven pts received AMSA in a similar dose schedule but DTIC was used in a 5-day schedule of 250 mg/m2/day. Twenty-five patients were evaluable for response in the AMSA group and 36 in the AMSA + DTIC group. The objective response to AMSA included 1(4%) partial response compared with 11 complete or partial responses (30%) with AMSA + DTIC therapy. The median lowest absolute granulocyte count was 1100/microliters in AMSA group compared with 1000/microliters in the AMSA + DTIC group. Severe neutropenia of less than 500 granulocytes/microliter was observed in 5 pts in the AMSA group compared with 13 pts in the AMSA + DTIC group. We concluded that AMSA has no significant activity against melanoma, although the combination of AMSA + DTIC seemed to be more active than DTIC alone.
authors.affiliation: Department of Medical Oncology, University of Texas M.D. Anderson Hospital and Tumor Institute, Houston 77030.
authors.forename: A
authors.initials: A
authors.lastname: Polyzos
authors.forename: S S
authors.initials: SS
authors.lastname: Legha
authors.forename: A M
authors.initials: AM
authors.lastname: Burgess
authors.forename: R S
authors.initials: RS
authors.lastname: Benjamin
authors.forename: G P
authors.initials: GP
authors.lastname: Bodey
mesh_terms: D000328:Adult; D000368:Aged; D000677:Amsacrine / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis
chemical_list: D000677:Amsacrine; D003606:Dacarbazine