PHASE II WBH AND IFOSFAMIDE/CARBOPLATIN/ETOPOSIDE THERAPY IN SARCOMA

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Two earlier studies resulted in the design of a phase II trial of 41.8-degree-celsius (x 60 min) extracorporeal whole body hyperthermia (WBH) with ICE, i.e., ifosfamide (5 g/m2), carboplatin (300 mg/m2), and etoposide given with WBH, as well as day 2 and 3 post WBH (100 mg/m2) for adult patients with refractory sarcoma. Twelve patients entered this trial; all were evaluable. Eight patients had a history of prior chemotherapy associated with disease progression. Following WBH/ICE, seven partial remissions were observed (58 percent); three patients experienced disease stabilization; the aforementioned ten patients each received four cycles of therapy. Two patients exhibited progressive disease. Episodes of WHO-graded (3; or 4) toxicity observed included: red blood cell (2;2); white blood cell (5;7); platelet (1;6); renal (1;6). Other toxicities (grade 1 and 2) included: anasarca, diarrhea, ventricular arrhythmias, pressure sores, and perioral herpes simplex. Based on an analysis of the toxicity data, an alternative WBH technology, i.e., radiant heat, was adopted to reduce morbidity. This technology developed at the University of Wisconsin, has eliminated the aforementioned toxicities (associated with extracorporeal WBH). To date (April 1996), seven of twelve patients have had responses in an ongoing radiant heat WBH trial at the University of Lubeck. This trial is now becoming a multi-institutional trial with the addition of the University of Wisconsin and the University of Essen. The results of this trial should provide a solid foundation for a multi-institutional phase III study.