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Phase I study of recombinant leukocyte a interferon (IFN‐α2A, roferon‐A) with doxorubicin in advanced malignant disease
Author(s) -
Creagan Edward T.,
Frytak Stephen,
Long Harry J.,
Kvols Larry K.
Publication year - 1989
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19890901)64:5<1034::aid-cncr2820640512>3.0.co;2-a
Subject(s) - medicine , doxorubicin , recombinant dna , malignant disease , interferon , immunology , disease , cancer research , oncology , virology , cancer , chemotherapy , biology , biochemistry , gene
Twenty‐six patients with advanced cancer received monthly intramuscular recombinant leukocyte A interferon (IFN‐α2A), 12 × 10 6 U/m 2 daily × 5 with escalating doses of doxorubicin, 25 to 40 mg/m 2 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 α‐fetoprotein reduction from 39,000 to 299 ng/ml. For Phase II investigations, the authors recommend the above IFN‐α2A dose with doxorubicin, 40 mg/m 2 , in patients with a performance score of 0 or 1 and no prior chemotherapy or significant radiation therapy which would enhance myelo‐suppression.