PHASE-II EVALUATION OF RECOMBINANT INTERFERON-ALPHA AND BCNU IN RECURRENT GLIOMA

The goal of this study was to determine the antitumor activity and tox icity of 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) plus recombinant interferon-alpha (IFN-alpha) in patients with recurrent glioma. As sin gle agents, both BCNU and IFN-alpha can cause tumor regression in pati ents with recurrent glioma. In vitro studies suggest synergy between t he two agents. Thirty-five patients in whom computerized tomography (C T) or magnetic resonance (MR) evidence was obtained of progressive ast rocytoma, oligoastrocytoma, or oligodendroglioma received recombinant IFN-alpha(2a) (12 X 10(6) U/m(2) intramuscularly) on Days 1 through 3 and BCNU (150 mg/m(2) intravenously) on Day 3 of each 6-week cycle. Al l patients had tumor progression despite radiation therapy and had rec eived no prior chemotherapy. Response was assessed by CT or MR evidenc e and by neurological examination while the patients were on a regimen of stable or decreasing doses of corticosteroids. All patients could be evaluated for response and toxicity. Twenty-nine percent of the pat ients demonstrated objective tumor regression; 37% remained stable for more than 6 months and 25% were stable for less than 6 months. The me dian duration of response to IFN-alpha and BCNU was 9.9 months and the median survival for all patients was 13.3 months. Toxicity consisted primarily of moderate myelosuppression, venous irritation, vomiting, f lulike symptoms, and transient reversible exacerbation of underlying n eurological symptoms. The use of BCNU plus IFN-alpha is a safe, active regimen in the treatment of patients with recurrent glioma who have f ailed to respond to prior radiation therapy. The contribution of IFN t o the antitumour activity observed in this study compared with that pr eviously described with BCNU alone cannot be assessed from this trial.