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

Study Overview
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Brief Summary
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Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis. Paclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.

Official Title
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Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Consolidation Paclitaxel/Ifosfamide/Cisplatin (TIP) Chemotherapy for High Risk Pediatric Germ Cell Tumor

Conditions
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Pediatric Germ Cell Tumor

Intervention / Treatment
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* Drug: TIP treatment (paclitaxel/ifosfamide/cisplatin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIP treatment arm<br> | Drug: TIP treatment (paclitaxel/ifosfamide/cisplatin)<br>* Paclitaxel 240mg/m2/day D1 (total 240mg/m2) Ifosfamide 1.5g/m2/day D2 5 (total 6g/m2) Cisplatin 25mg/m2/day D2 5 (total 100mg/m2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response Rate |  | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate |  | 12 weeks and 18 weeks | 
| Complete Response Rate |  | 18 weeks | 
| Overall Survival |  | 3 years | 
| Event Free Survival |  | 3 years |