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

Byline: Bruce J. Giantonio (1), Howard Hochster (2), Ronald Blum (2), Peter H. Wiernik (3), Gary R. Hudes (4), John Kirkwood (5), Donald Trump (5), Martin M. Oken (6) Keywords: poly I-C; interferon inducers; renal carcinoma; lymphoma 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/m.sup.2 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. Author Affiliation: (1) University of Pennsylvania, Philadelphia, Pennsylvania, USA (2) New York University Medical Center, New York, New York, USA (3) Albert Einstein College of Medicine, Bronx, New York, USA (4) Fox Chase Cancer center, Philadelphia, Pennsylvania, USA (5) University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA (6) Virginia Piper Cancer Institute, Minneapolis, Minnesota, USA Article History: Registration Date: 11/10/2004