Rationale for and conduct of a phase I clinical trial with interferon alfa-2b plus doxorubicin.
A human tumor cloning system was utilized to screen for the antitumor activity of recombinant interferon alfa-2b (Intron A) alone and in combination with standard antineoplastic agents. These in vitro studies confirmed synergistic effects of alfa-2b plus doxorubicin against primary human tumors. Based on those in vitro findings, a phase I study has been conducted by Sarosy and colleagues that demonstrated that recombinant interferon alpha-2b and doxorubicin could be given together. Myelosuppression was the dose-limiting toxicity. Because responses were noted in the phase I trials with the combination, phase II trials of the combination are warranted. Additional phase I studies that should be pursued include recombinant interferon alpha-2b plus 5-fluorouracil, interferon plus cisplatinum, and interferon plus DTIC.
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004317:Doxorubicin / Q000008:administration & dosage*; D004341:Drug Evaluation; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage* / Q000009:adverse effects; D009369:Neoplasms / Q000628:therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D014410:Tumor Stem Cell Assay
D007370:Interferon Type I; D011994:Recombinant Proteins; D004317:Doxorubicin