Phase II evaluation of PALA in patients with refractory metastatic sarcomas

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Abstract
The efficacy of PALA was evaluated in 22 patients with metastatic soft tissue and bone sarcomas. The 20 evaluable patients had received a median of 3 prior chemotherapeutic regimens, including an adriamycin combination, to which 8 had shown response. PALA was administered at 2-wk intervals. Sixteen patients received 6 g/m2 over 1 h i.v. as their initial dose, while 6 patients received 5 g/m2. The major side effects were skin rash, stomatitis, diarrhea, nausea and vomiting. Significant myelosuppression was not seen. Two patients had stabilization of disease for periods of 10 and 13 wk. At the dose and schedule used in this trial, PALA was not effective against advanced adult sarcoma.