INITIAL CLINICAL-STUDY WITH N-(PHOSPHONACETYL)-L-ASPARTIC ACID (PALA) IN PATIENTS WITH ADVANCED CANCER

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  • 1 January 1980
    • journal article
    • research article
    • Vol. 64  (4-5) , 617-624
Abstract
Patients (37) with inoperable malignancies were given 75 courses of N-(phosphonacetyl)-L-aspartic acid (PALA). Of these patients, 27 received PALA as a continuous i.v. infusion over 24 h at dose levels ranging from 500-10,500 mg/m2 of estimated body surface area. Ten patients were given PALA by continuous i.v. infusion over 120 h at total doses ranging from 4000 to 8700 mg/m2. The dose-limiting toxic effects occurred in the skin (erythema, vesiculation and bullae) and gastrointestinal mucosa (oral pain, cheilosis, oral mucosal ulceration, diarrhea and hematochezia). Toxic reactions seemed more pronounced in patients with 3rd-space fluid compartments. Myelosuppression was severe only in patients with pre-existing marrow dysfunction from neoplastic infiltration. No renal, hepatic, cardiac or neurologic toxicity was seen. No cumulative toxic effects were evident in 14 patients who received repeated courses of PALA at 21 day intervals. For patients without 3rd-space fluid, 8700 mg/m2 per 24 h or 6500 mg/m2 per 120 h were well-tolerated doses. One patient with chondrosarcoma had a partial response lasting 5 mo.