HYPERTHERMIA FOR THE TREATMENT OF PATIENTS WITH MALIGNANT GERM-CELL TUMORS - A PHASE-I PHASE-II STUDY IN 10 CHILDREN AND ADOLESCENTS WITH RECURRENT OR REFRACTORY TUMORS/

BACKGROUND. Extracranial nontesticular germ cell tumors (GCTs) are rar e malignancies in children and adolescents. Cisplatin-containing regim ens and complete tumor resection are important determinants for a favo rable outcome; however, patients with recurrent tumors that cannot be eradicated by surgical procedures and chemotherapy have a poor prognos is. Noninvasive electromagnetic technologies for superficial and regio nal deep hyperthermia (RHT) are under investigation to enhance local t umor control in various malignancies. The objectives of this Phase I/I I study were to examine 1) whether RHT can be used in combination with platinum-based chemotherapy with acceptable toxicity in children and adolescents and 2) whether this combined regimen can induce objective tumor response in patients with malignant nontesticular GCT that persi sted or recurred locoregionally after validated, intensive, cisplatin- based chemotherapy +/- surgery as unsuccessful first-line treatment. M ETHODS. The authors studied the effects of RHT induced by electromagne tic waves in combination with platinum-based chemotherapy in ten child ren and adolescents with recurrent or refractory GCTs. RESULTS. Seven of ten patients with recurrent or refractory GCTs had objective respon ses. Of these, two patients had a partial response and five patients h ad a complete response. CONCLUSIONS. The results of the current study found that combined RHT and platinum-based chemotherapy can be used in children and adolescents. This regimen was found to induce objective tumor response in 70% of study patients with recurrent or refractory G CTs. The results thus far are encouraging and the study has been exten ded to patients with a poor response to first-line treatment. (C) 1998 American Cancer Society.