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

NCT ID: NCT05455918

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-26
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TIP treatment arm

Group Type: EXPERIMENTAL

TIP treatment (paclitaxel/ifosfamide/cisplatin)

Intervention Type: 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)

Interventions

TIP treatment (paclitaxel/ifosfamide/cisplatin)

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)

Intervention Type: DRUG

Eligibility Criteria

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

1. embryonal carcinoma

2. choriocarcinoma

3. yolk sac tumor

4. teratoma with malignant germ cell tumor elements

• High risk definition

1. More than 11 years old, male or female

2. Less than 11 years old, male or female

1. Extragonodal germ cell tumor, stage III

2. Extragonodal germ cell tumor, stage IV

3. 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

1. Bone marrow : Absolute neutrophil count >=1000/µL , platelet >= 100000/µL

2. Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)

3. Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL

4. Cardiac Function : Ejection fraction ≥ 50%

5. Uncontrolled infection

6. Uncontrolled urinary obstruction

7. Uncontrolled cystitis

• Followings will be excluded

1. Mature teratoma

2. Gliomatosis Peritonei

3. Low Risk Germ Cell Tumor

4. testicular stage I

5. ovarian stage I

6. recurrent, refractory tumor

• Concomitant other trial agent beside the agents in this trial
• Concomitant chemotherapeutic agents besides the agents in this trial

1. Concomitant tumor other than germ cell tumor

2. Other trial agents

3. Other chemotherapeutic agents

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jung Woo Han

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jung Woo Han

Role: CONTACT

JWHAN@yuhs.ac

82-2-2228-2050

Facility Contacts

Jung Woo Han

Role: primary

JWHAN@yuhs.ac

82-2-2228-2050

Other Identifiers

4-2020-0658

Identifier Type: -

Identifier Source: org_study_id