A phase II study of 5,6-dihydro-5-azacytidine hydrochloride in disseminated malignant melanoma

Am J Clin Oncol. 1993 Jun;16(3):243-4. doi: 10.1097/00000421-199306000-00010.

Abstract

Forty patients with measurable disseminated malignant melanoma and no prior chemotherapy received monthly DHAC, 5 g/m2/24 h, as a continuous infusion. Among 26 "good risk patients" (ECOG performance score 0, 1 and no prior biological therapy), we observed 3 objective regressions. Among 14 "poor-risk patients" (ECOG PS 2 or prior biological therapy), we observed no objective regressions. For all patients, median time to progression and survival were 1 month and 6.7 months, respectively. Transient pleuritic chest pain and mild nausea and vomiting were the most common complications. We were especially impressed with a complete response (CR) for 11+ months in a 43-year-old woman with extensive visceral metastases and another CR lasting > 4.7 months in a 36-year-old woman with nonvisceral metastatic disease. The absence of myelosuppression raises intriguing possibilities for combination regimens including DHAC in the management of malignant melanoma.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / pharmacology
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Azacitidine / adverse effects
  • Azacitidine / analogs & derivatives*
  • Azacitidine / pharmacology
  • Azacitidine / therapeutic use
  • Biopsy
  • Chest Pain / chemically induced
  • Female
  • Humans
  • Immunologic Factors / therapeutic use
  • Infusions, Intravenous
  • Male
  • Melanoma / drug therapy*
  • Melanoma / mortality
  • Melanoma / secondary
  • Middle Aged
  • Nausea / chemically induced
  • Remission Induction
  • Risk Factors
  • Severity of Illness Index
  • Survival Rate
  • Vomiting / chemically induced

Substances

  • Antimetabolites, Antineoplastic
  • Immunologic Factors
  • 5,6-dihydro-5-azacytidine
  • Azacitidine