Phase I study of recombinant leukocyte A interferon (IFN-alpha 2A, Roferon-A) with doxorubicin in advanced malignant disease

Cancer. 1989 Sep 1;64(5):1034-7. doi: 10.1002/1097-0142(19890901)64:5<1034::aid-cncr2820640512>3.0.co;2-a.

Abstract

Twenty-six patients with advanced cancer received monthly intramuscular recombinant leukocyte A interferon (IFN-alpha 2A), 12 X 10(6) U/m2 daily X 5 with escalating doses of doxorubicin, 25 to 40 mg/m2 on day 3. As anticipated, dose-limiting toxicities were an influenza-type syndrome and myelosuppression. A clinically meaningful and dramatic partial response of hepatocellular carcinoma persisted for 11.5 months associated with an alpha-fetoprotein reduction from 39,000 to 299 ng/ml. For Phase II investigations, the authors recommend the above IFN-alpha 2A dose with doxorubicin, 40 mg/m2, in patients with a performance score of 0 or 1 and no prior chemotherapy or significant radiation therapy which would enhance myelosuppression.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma / drug therapy
  • Carcinoma, Hepatocellular / drug therapy
  • Doxorubicin / administration & dosage*
  • Doxorubicin / adverse effects
  • Doxorubicin / therapeutic use
  • Drug Evaluation
  • Female
  • Humans
  • Interferon Type I / administration & dosage*
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage*
  • Interferon-alpha / adverse effects
  • Interferon-alpha / therapeutic use
  • Leukopenia / chemically induced
  • Liver Neoplasms / drug therapy
  • Male
  • Middle Aged
  • Neoplasms / drug therapy*
  • Recombinant Proteins
  • Thyroid Neoplasms / drug therapy
  • alpha-Fetoproteins / metabolism

Substances

  • Interferon Type I
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • alpha-Fetoproteins
  • Doxorubicin