Abstract
Purpose: Phase II studies were conducted toevaluate the safety and efficacy of the interferon inducerPoly ICLC at low doses in advanced renal cancer and relapsedor refractory lymphoma. Patients and methods:Twenty-nine patients with advanced renal carcinoma and elevenpatients with lymphoma were treated with poly ICLC. Patientsreceived 0.25 mg/m2 of poly ICLC intravenouslytwice weekly three days apart until progression orunacceptable toxicity. Results: There were noobjective responses. Six patients with renal carcinoma hadstable disease as best response with one patient receiving 62weeks of therapy. Toxicity included grade 3 anemia in 8patients and grade 4 anemia in one patient. All patients wereanemic prior to entry with a median grade 2 anemia atbaseline. Grade 4 neutropenia, thrombocytopenia and injectionsite pain occurred in one patient each. Grade 3 fever, chillsor fatigue occurred in four, three, and three patientsrespectively. Any grade fever occurred in 10 patients(25.6%) and any grade chills occurred in 9 patients(23.1%). Conclusion: Poly ICLC at this doseand schedule is well tolerated in both patient populations andis inactive in renal carcinoma.
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DeMaeyer E, J. D-G: Interferons and regulatory cytokines. New York, Wiley, 1988, pp 1–448
Witt PL: Chemically defined immunomodulators and interferon inducers. In: DeVita VT Jr, Hellman S, Rosenberg SA (eds) Biologic Therapy of Cancer. 2nd edition. Philadelphia, J.B. Lippincott, 1995, pp 787–793
Levy HB, Baer G, Baron S, Bucker CE, Gibbs Ci, Iadarola MJ, London WT, Rice J: A modified polyriboinosinicpolylribocytidylic acid complex that induces interferon in primates. J Infect Dis 132: 434–439, 1975
Levine AS, Sivulich M, Wiernik P, Levy HB: Initial clinical trials in cancer patients of polyriboinosinic-polyribocytidylic acid stabilized with poly-L-lysine in carboxymethyl cellulose [poly (ICLC)], a highly effective interferon inducer. Cancer Res 39: 1645–1650, 1979
Levine AS, Sherwin SA: Clinical trials of interferon inducers. In: Sikora K (ed) Interferon and Cancer. Plenum Press, New York, 1983, pp 183–201
Lampkin BC, Levine AS, Levy H, Krivit W, Hammond D: Phase II trial of a complex polyriboinosinic-polyribocytidylic acid with poly-L-lysine and carboxymethyl cellulose in the treatment of children with acute leukemia and neuroblastoma: a report from the Children's cancer Study Group. Cancer Res 45: 5904–5909, 1985
Krown SE, Kerr D, Stewart WEI, Pollack MS, Cunningham-Rundles S, Hirshaut Y, Pinsky CM, Levy HB, Oettgen HF: Phase I trial of poly ICLC in patients with advanced cancer. In: Hersh EM, Chirigos MA, Mastrangelo MJ (eds) Augmenting Agents in Cancer Therapy. Raven Press, New York, 1981, pp 165–176
Sammons ML, Stephen EL, Levy HB, Baron S, Hilmas DE: Interferon induction in cynomologous and rhesus monkeys after repeated doses of a modified polyriboinusinicpolyribocytidylic acid complex. Antimicrobial Agents Chemother 11: 80–83, 1977
Ewel CH, Urba WJ, Kopp WC, Smith JWd, Steis RG, Rossio JL, Longo DL, Jones MJ, Alvord WG, Pinsky CM: Polyinosinic-polycytidylic acid complexed with poly-L-lysine and carboxymethylcellulose in combination with interleukin 2 in patients with cancer: clinical and immunological effects. Cancer Res 52: 3005–3010, 1992 Address for offprints: Bruce J. Giantonio, MD 51 N. 39th Street, Suite 103 Philadelphia, PA 19104
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Giantonio, B.J., Hochster, H., Blum, R. et al. Toxicity and Response Evaluation of the Interferon Inducer Poly ICLC Administered at Low Dose in Advanced Renal Carcinoma and Relapsed or Refractory Lymphoma: A Report of Two Clinical Trials of the Eastern Cooperative Oncology Group. Invest New Drugs 19, 89–92 (2001). https://doi.org/10.1023/A:1006458232384
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DOI: https://doi.org/10.1023/A:1006458232384