Phase II study of vindesine and dacarbazine with or without non-specific stimulation of the immune system in patients with metastatic melanoma

Eur J Cancer. 1993;29A(5):708-11. doi: 10.1016/s0959-8049(05)80351-x.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Agranulocytosis / chemically induced
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • BCG Vaccine / administration & dosage
  • Dacarbazine / administration & dosage
  • Drug Administration Schedule
  • Female
  • Humans
  • Infusions, Intravenous
  • Male
  • Melanoma / drug therapy
  • Melanoma / mortality
  • Melanoma / secondary*
  • Middle Aged
  • Prognosis
  • Vindesine / administration & dosage


  • BCG Vaccine
  • Dacarbazine
  • Vindesine