Phase I and pharmacological studies of pentamethylmelamine administered by 24-hour intravenous infusion

Cancer Res. 1981 Apr;41(4):1402-6.

Abstract

A Phase I study of pentamethylmelamine (PMM) was conducted, administering the drug as a 24-hr i.v. infusion once weekly for 3 weeks. Doses ranged from 80 to 3000 mg/sq m/week. Twenty-six evaluable patients received a total of 30 courses of PMM. The median performance status of the patients was 60% (range, 40 to 90%), and the median age was 58 years (range, 43 to 72 years). The highest tolerated dose was 2000 mb/sq m/week. Nausea and vomiting were the dose-limiting toxicities; myelosuppression was neither consistent nor severe. One objective response lasting 10 months was noted in a patient with renal cancer. Pharmacokinetic studies using [ring-14C]PMM demonstrated a postinfusion half-life of 14C of approximately 12 hr, with the majority of the radiolabel excreted in the urine. PMM was introduced as a parenteral form of hexamethylmelamine. The present schedule does not permit administration of PMM in a dose greater than the tolerated dose of hexamethylmelamine and does not appear to offer an advantage over the p.o. use of the parent compound.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Altretamine / administration & dosage*
  • Altretamine / adverse effects
  • Altretamine / analogs & derivatives
  • Altretamine / urine
  • Antineoplastic Agents / administration & dosage*
  • Drug Administration Schedule
  • Drug Evaluation
  • Female
  • Humans
  • Infusions, Parenteral
  • Kidney Neoplasms / drug therapy*
  • Lung Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Prognosis
  • Triazines / administration & dosage*
  • Vomiting / chemically induced

Substances

  • Antineoplastic Agents
  • Triazines
  • Altretamine
  • pentamethylmelamine