A phase I-II trial of multiple-dose polyriboinosic-polyribocytidylic acid in patieonts with leukemia or solid tumors

J Natl Cancer Inst. 1976 Sep;57(3):599-602. doi: 10.1093/jnci/57.3.599.


Polyriboinosinic-polyribocytidylic acid (poly I - poly C), an interferon inducer, was administered in multiple doses of 0.3-75 mg/m2 to 26 patients with a variety of solid tumors, 9 with acute leukemia, and 2 with chronic myelogenous leukemia in blast crisis. Forty-four separate drug trials were comprised of various schedules and routes of administration. Toxic reactions included fever (in 66% of the trials), transient elevation of serum glutamic-oxaloacetic transaminase and serum glutamic-pyruvic transaminase (25%), minimal laboratory evidence of coagulation abnormalities (59%), and hypersensitivity (5%). These toxic manifestations did not relate to dose level or magnitude of interferon induction. Poly I - poly C administered iv induced low serum concentrations of interferon in 24/38 trials (63%), but the correlation between drug dose and peak interferon titer was not linear. Poly I - poly C administered iv or im was not effective as an inducer of interferon in the cerebrospinal fluid. Similarly, poly I - poly C administered im or by inhalation did not produce detectable serum levels of interferon. No patients experienced an objective tumor response to the administration of poly I - poly C, and most (76%) had progression of their disease while receiving the drug.

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Child
  • Child, Preschool
  • Female
  • Fever / chemically induced
  • Humans
  • Interferons / blood
  • Interferons / metabolism
  • Leukemia / drug therapy*
  • Male
  • Middle Aged
  • Neoplasms / drug therapy*
  • Poly I-C / administration & dosage
  • Poly I-C / adverse effects
  • Poly I-C / therapeutic use*


  • Interferons
  • Poly I-C