Phase II study of vindesine and dacarbazine with or without non-specific stimulation of the immune system in patients with metastatic melanoma.
A single dose of dacarbazine (DTIC), followed by a 5-day intravenous infusion of vindesine (VDS) was administered every 3 weeks to 103 patients with metastatic melanoma. One half of the patients were randomised to receive intravenous methanol extraction residue (MER) of bacillus Calmette-Guerin (BCG) in addition to chemotherapy, on days 7 and 14 of each course. 98 patients were evaluable. The response rates in treatment groups were 16 and 17%, respectively (confidence interval 9-24%). Neither the response rate nor the survival improved when MER was added to chemotherapy. Toxicity was moderate except for a significant granulocytopenia. The combination of DTIC and VDS is not more effective than DTIC alone and has added neurotoxicity.
Verschraegen
C F
CF
University of Texas Health Sciences Center, Department of Internal Medicine, Houston 77030.
Legha
S S
SS
Hersh
E M
EM
Plager
C
C
Papadopoulos
N
N
Burgess
M A
MA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000008:administration & dosage; D003606:Dacarbazine / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000401:mortality / Q000556:secondary*; D008875:Middle Aged; D011379:Prognosis; D014751:Vindesine / Q000008:administration & dosage
D001500:BCG Vaccine; D003606:Dacarbazine; D014751:Vindesine