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Phase I Study of ₂-Interferon plus Doxorubicin in Patients with Solid Tumors¹

Medicine/Oncology, University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284 [G. A. S., D. D. V. H., J. G. K., D. L. K.]; Brooke Army Medical Center, Beach Pavilion, Fort Sam Houston, Texas 78234 [T. D. B., K. L. B.]; and Schering Corporation, Kenilworth, New Jersey 07033 [R. J. S., J. P. G.]

Cytotoxic chemotherapy and interferon have shown synergistic antitumor activity in vitro. The purpose of this study was to determine the maximally tolerated dose of doxorubicin given every 3 weeks, in patients receiving recombinant ₂-interferon [10 x 10⁶ IU/m² s.c. three times per week³ (Monday, Wednesday, and Friday)] during the first 2 weeks of each cycle of doxorubicin. Fourteen patients received a total of 41 cycles. Hematological toxicity was dose limiting with granulocytopenia (total granulocyte count, <1000) occurring in 50% of patients treated with doxorubicin at 40 mg/m² and in 25% of patients treated with doxorubicin at 30 mg/m². Nonhematological toxicities included a flu-like syndrome, alopecia, nausea, vomiting, diarrhea, and transient mild increases in liver function tests. A partial response was seen in one patient with metastatic squamous cell carcinoma of the skin and in another patient with metastatic adenocarcinoma of the pancreas. Concomitant administration of recombinant ₂-interferon given on this schedule limits the amount of doxorubicin that can be administered. However, the responses noted in this study are encouraging enough to warrant additional studies of doxorubicin plus recombinant ₂-interferon.

¹ This investigation was supported in part by a grant from the Schering Corporation and by the USPHS, National Research Service Award CA09434 from the National Cancer Institute (G. S.), as well as by the General Clinical Research Center, NIH, Department of Health and Human Services (Grant RR-01346), and the Clinical and Support Services of the Audie L. Murphy Memorial Veterans Hospital, San Antonio, TX.

² To whom requests for reprints should be addressed, at Investigational Drug Branch, Landow Bldg., Room 4C17, NIH, Bethesda, MD 20205.

Received 12/19/85. Revised 5/22/86. Accepted 5/29/86.