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An Eastern Cooperative Oncology Group Phase I—II Pilot Study of Polyriboinosinic-Polyribocytidylic Acid Poly-L-lysine Complex in Patients with Metastatic Malignant Melanoma

Hawkins Michael J.; Levin, Mark; Borden, Ernest C.
Journal of Immunotherapy: December 1985
Proceedings: Clinical Studies: PDF Only


Sixteen patients with metastatic malignant melanoma were treated with poly(I,C)-LC 5 mg/m2 twice weekly by intravenous injection. No antitumor responses occurred. Fever (frequently >40°C) and fatigue were dose limiting toxicities. One patient developed a fever of 42.2°C when poly(I,C)-LC was given on 2 consecutive days. Interferon was consistently detected in the serum 8 h after a single injection of poly(I,C)-LC (median titer 199 U/ml). No enhancement of interferon induction was detected on the second day when poly(I,C)-LC was given on 2 consecutive days.

Received June 15, 1985; accepted June 15, 1985.

Address correspondence and reprint requests to Dr. M. J. Hawkins at Biologics Evaluation Section, IDB, CTEP, DCT, NCI, 4C19 Landow Building, 7910 Woodmont Avenue, Bethesda, MD 20892, U.S.A.

© Lippincott-Raven Publishers.