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

NCT05455918 | Recruiting Phase 2

• 1 other identifier: 4-2020-0658
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  12weeks

Secondary Outcomes (4)

• Overall Response Rate

  12 weeks and 18 weeks

• Complete Response Rate

  18 weeks

• Overall Survival

  3 years

• Event Free Survival

  3 years

Study Arms (1)

TIP treatment arm

EXPERIMENTAL

Drug: TIP treatment (paclitaxel/ifosfamide/cisplatin)

Interventions

TIP treatment (paclitaxel/ifosfamide/cisplatin) DRUG

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)

TIP treatment arm

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jung Woo Han

  Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Woo Han

CONTACT

82-2-2228-2050; JWHAN@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: July 26, 2020
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)