PHASE-I TRIAL OF PALA

  • 1 January 1980
    • journal article
    • research article
    • Vol. 64  (12) , 1301-1305
Abstract
PALA [N-(phosphonacetyl)-L-aspartate] was given i.v. on a weekly schedule to 32 patients with advanced malignant tumors. A course of treatment consisted of 3 weekly doses. Patients were treated at 8 dose levels, ranging from 900-6750 mg/m2. Gastrointestinal toxicity (diarrhea) and skin rash were dose-limiting. No consistent myelosuppression occurred; no renal or hepatic toxicity was observed. Two patients who did not have metastatic intracranial disease experienced episodes of encephalopathy and seizures. No major therapeutic responses were observed during this phase I trial; minor responses (.gtoreq. 25% tumor decrease) occurred in 3 patients (1 with adenocarcinoma of the lung and 2 with epidermoid carcinoma of the bladder). Doses of 4500 mg/m2 per wk for patients with a performance status .gtoreq. 70 and 3750 mg/m2 per wk for patients with a lower performance status are recommended for phase II studies.