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

Phase II Study of Vindesine and Dacarbazine With or Without Non-Specific Stimulation of the Immune System in Patients With Metastatic Melanoma

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Clinical Trial

Phase II Study of Vindesine and Dacarbazine With or Without Non-Specific Stimulation of the Immune System in Patients With Metastatic Melanoma

C F Verschraegen et al. Eur J Cancer. .

Abstract

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.

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