Long-term Treatment of Malignant Gliomas with Intramuscularly Administered Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose: An Open Pilot Study

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Abstract
POLYINOSINIC-POLYCYTIDYLIC ACID STABILIZED with polylysine and carboxymethylcellulose (poly-ICLC) (10-50 mcg/kg, administered intramuscularly one to three times weekly) was given for ≤56 months to 38 patients ;cc with malignant gliomas. There was minimal or no toxicity. Twenty of 30 patients (66%) receiving at least twice red weekly poly-ICLC showed regression or stabilization of gadolinium-enhancing tumor, as revealed by magnetic resonance imaging (median = 65% volume decrease). All but one patient with anaplastic astrocytomas who received continuous poly-ICLC remain alive, with a median progression-free survival of 54 months from diagnosis Median Kaplan-Meier survival is 19 months for patients with glioblastomas who receive at least twice weekly poly-ICLC treatments. Tumor response was associated with 2',5-oligoadenylate synthetase activation (P = 0.03) but not with serum interferon. We hypothesize clinical activation by poly-ICLC of a basic host tumor suppressor system Prolonged, quality survival with tumor stabilization or regression confirmed by magnetic resonance imaging tor mos ( patients with anaplastic astrocytomas and glioblastomas suggests that more extensive laboratory and controlled clinical studies are warranted. The concept of long-term, broad spectrum stimulation of host defenses with nontoxic,% inexpensive double-stranded ribonucleic acids, such as low-dose poly-ICLC, may be applicable to the treatment ot other malignancies.

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