Controlled study with imidazole carboxamide (DTIC), DTIC + bacillus Calmette-Guérin (BCG), and DTIC + corynebacterium parvum in advanced malignant melanoma. W.H.O. Collaborating Centres for Evaluation of Methods of Diagnosis and Treatment of Melanoma

Tumori. 1984 Feb 29;70(1):41-8.

Abstract

From 1976 to 1980, 377 randomized patients were entered in a multicentric study supported by the W.H.O. Melanoma Group. In this report, only 196 patients are considered for analysis: 31.6% were excluded because of inadequate treatment or protocol violations. Three arms of treatment were compared: DTIC alone, DTIC plus bacillus Calmette-Guérin, and DTIC plus Corynebacterium parvum. No significant difference in terms of complete response plus partial response was detected among the three regimens. Twenty-five patients (12.7%) responded with complete tumor regression, and 18 (9.3%) with partial regression. Complete plus partial responses were thus achieved in 22% of evaluable patients. Responders had a longer median survival than nonresponders. Overall median survival was 6 months. Brain metastases were detected in 17% of the patients. Median time from the beginning of treatment to the diagnosis of CNS involvement was 4 months. There is no evidence that active aspecific immunotherapy added to DTIC increases the response rate in patients with disseminated disease. The toxic effects were acceptable, and no drug-related death was observed.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • BCG Vaccine / administration & dosage*
  • Bacterial Vaccines / administration & dosage*
  • Bacterial Vaccines / adverse effects
  • Brain Neoplasms / mortality
  • Brain Neoplasms / secondary
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Dacarbazine / administration & dosage
  • Dacarbazine / therapeutic use*
  • Female
  • Fever / etiology
  • Humans
  • Leukopenia / etiology
  • Male
  • Melanoma / pathology
  • Melanoma / therapy*
  • Middle Aged
  • Nausea / etiology
  • Propionibacterium acnes / immunology*
  • Sex Factors
  • Time Factors

Substances

  • BCG Vaccine
  • Bacterial Vaccines
  • Dacarbazine