Phase I trial of combination therapy of cancer with N-phosphonacetyl-L-aspartic acid and dipyridamole

Cancer Chemother Pharmacol. 1987;19(1):80-3. doi: 10.1007/BF00296262.

Abstract

While N-phosphonacetyl-L-aspartic acid (PALA), an inhibitor of de novo pyrimidine biosynthesis, demonstrated a unique spectrum of activity during preclinical drug evaluation, multiple clinical trials have shown it to possess minimal clinical activity. One explanation for the disappointing results is the possibility that tumor cells are able to utilize circulating uridine in the synthesis of pyrimidines (salvage pathway). Dipyridamole, an inhibitor of nucleoside transport, has been demonstrated experimentally to potentiate the cytotoxicity of PALA significantly. In addition, this agent has a long safety record when used clinically in man. A phase I trial of this two-drug combination was therefore conducted, with a fixed oral dose of dipyridamole (50 mg/m2 every 6 h) and an escalating i.v. dose of PALA administered every 3 weeks. The dose-limiting toxicity with this schedule was diarrhea and abdominal cramping pain at a PALA dose of 3900-4200 mg/m2. Among the 65 patients participating in this trial 4 objective responses (2 partial, 2 minimal) were observed. Because of the potential for unique clinical synergy between PALA and dipyridamole further investigation should be considered.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Aspartic Acid / administration & dosage
  • Aspartic Acid / adverse effects
  • Aspartic Acid / analogs & derivatives*
  • Dipyridamole / administration & dosage*
  • Dipyridamole / adverse effects
  • Drug Evaluation
  • Drug Synergism
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Headache / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / blood
  • Neoplasms / drug therapy*
  • Organophosphorus Compounds / administration & dosage*
  • Phosphonoacetic Acid / administration & dosage*
  • Phosphonoacetic Acid / adverse effects
  • Phosphonoacetic Acid / analogs & derivatives
  • Uridine / metabolism

Substances

  • Organophosphorus Compounds
  • Aspartic Acid
  • Dipyridamole
  • sparfosic acid
  • Phosphonoacetic Acid
  • Uridine