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

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.

• Authors: E T Creagan, D J Schaid, L C Hartmann, C L Loprinzi
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 16 Issue 3 Pg. 243-4 (Jun 1993) ISSN: 0277-3732 [Print] United States
• PMID: 7687819 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

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

Topics

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