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.
OBJECTIVE
Phase II studies were conducted to evaluate the safety and efficacy of the interferon inducer Poly ICLC at low doses in advanced renal cancer and relapsed or refractory lymphoma.


METHODS
Twenty-nine patients with advanced renal carcinoma and eleven patients with lymphoma were treated with poly ICLC. Patients received 0.25 mg/m2 of poly ICLC intravenously twice weekly three days apart until progression or unacceptable toxicity.


RESULTS
There were no objective responses. Six patients with renal carcinoma 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 median grade 2 anemia at baseline. Grade 4 neutropenia, thrombocytopenia and injection site pain occurred in one patient each. Grade 3 fever, chills or fatigue occurred in four, three, and three patients respectively. Any grade fever occurred in 10 patients (25.6%) and any grade chills occurred in 9 patients (23.1%).


CONCLUSIONS
Poly ICLC at this dose and schedule is well tolerated in both patient populations and is inactive in renal carcinoma.
Giantonio
B J
BJ
University of Pennsylvania, Philadelphia, USA.
Hochster
H
H
Blum
R
R
Wiernik
P H
PH
Hudes
G R
GR
Kirkwood
J
J
Trump
D
D
Oken
M M
MM
D000328:Adult; D000368:Aged; D002266:Carboxymethylcellulose Sodium / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007369:Interferon Inducers / Q000008:administration & dosage* / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008223:Lymphoma / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local; D009503:Neutropenia / Q000139:chemically induced; D011070:Poly I-C / Q000008:administration & dosage* / Q000009:adverse effects; D011107:Polylysine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
D007369:Interferon Inducers; D011107:Polylysine; C019531:poly ICLC; D002266:Carboxymethylcellulose Sodium; D011070:Poly I-C