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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age1-20
SponsorYonsei University

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TIP treatment (paclitaxel/ifosfamide/cisplatin)

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators