PMID: 9166477Oct 1, 1995Paper

Phase I dose-escalation study of tumor necrosis factor-alpha and concomitant radiation therapy

The Cancer Journal From Scientific American
D E HallahanR R Weichselbaum

Abstract

Tumor necrosis factor-alpha enhances x-ray killing of human tumor cells in vitro and enhances tumor control when combined with radiation in animal tumor models. To determine the toxicity and maximal tolerated dose of tumor necrosis factor-alpha given daily during radiotherapy, we conducted a phase I dose-escalation study combining tumor necrosis factor-alpha and radiation. Thirty-one patients, including 14 patients with locally advanced primary tumors and 17 patients with metastatic sites, were entered into this study. Recombinant human tumor necrosis factor-alpha was administered intravenously at doses ranging from 10 microg/m2 to 150 microg/m2 4 hours prior to each radiation therapy session, which was given on consecutive days for a minimum of 2 weeks. Radiation was prescribed to localized fields, with dose fractions ranging from 150 to 300 cGy/day for palliation or control of locally advanced tumors. Major toxicity requiring withdrawal from the study was independent of tumor necrosis factor-alpha dose and occurred in seven patients. Symptoms included angina in two patients, and hypotension, respiratory distress, atrial fibrillation, allergic reaction, and progressive leukopenia in one patient each. A tumor necrosis factor-al...Continue Reading

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