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

Purpose: Phase II studies were conducted to evaluate the safety and efficac y of the interferon inducer Poly ICLC at low doses in advanced renal cancer and relapsed or refractory lymphoma. Patients and methods: Twenty-nine pat ients with advanced renal carcinoma and eleven patients with lymphoma were treated with poly ICLC. Patients received 0.25 mg/m(2) of poly ICLC intrave nously twice weekly three days apart until progression or unacceptable toxi city. Results: There were no objective responses. Six patients with renal c arcinoma had stable disease as best response with one patient receiving 62 weeks of therapy. Toxicity included grade 3 anemia in 8 patients and grade 4 anemia in one patient. All patients were anemic prior to entry with a med ian grade 2 anemia at baseline. Grade 4 neutropenia, thrombocytopenia and i njection site pain occurred in one patient each. Grade 3 fever, chills or f atigue occurred in four, three, and three patients respectively. Any grade fever occurred in 10 patients (25.6%) and any grade chills occurred in 9 pa tients (23.1%). Conclusion: Poly ICLC at this dose and schedule is well tol erated in both patient populations and is inactive in renal carcinoma.