Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor

Inclusion criteria

• Over 1 year old and less than 20 years old
• Pathologically or cytologically diagnosed germ cell tumor
• Germ cell tumor which has not been treated previously
• Higher than stage II (stage I should be excluded)
• Pathologic type

• embryonal carcinoma
• choriocarcinoma
• yolk sac tumor
• teratoma with malignant germ cell tumor elements
• High risk definition

• More than 11 years old, male or female
• Less than 11 years old, male or female

• Extragonodal germ cell tumor, stage III
• Extragonodal germ cell tumor, stage IV
• Ovarian germ cell tumor, stage IV
• More than 8 weeks of life expectancy
• performance level : ECOG Performance score 0, 1, or 2
• informed consent should be obtained

Exclusion criteria

• pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
• previously reported allergy or hypersensitivity to trial chemotherapeutic agent
• severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
• Acceptable organ functions

• Bone marrow : Absolute neutrophil count >=1000/µL , platelet >= 100000/µL
• Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL
• Cardiac Function : Ejection fraction ≥ 50%
• Uncontrolled infection
• Uncontrolled urinary obstruction
• Uncontrolled cystitis
• Followings will be excluded

• Mature teratoma
• Gliomatosis Peritonei
• Low Risk Germ Cell Tumor
• testicular stage I
• ovarian stage I
• recurrent, refractory tumor
• Concomitant other trial agent beside the agents in this trial
• Concomitant chemotherapeutic agents besides the agents in this trial

• Concomitant tumor other than germ cell tumor
• Other trial agents
• Other chemotherapeutic agents