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

Pediatric Germ Cell Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455918
• Other study ID #: 4-2020-0658
• Status: Recruiting
• Phase: Phase 2
• Start date: July 26, 2020
• Est. completion date: June 2028

Study information

• Verified date: July 2022
• Source: Yonsei University
• Contact: Jung Woo Han
• Phone: 82-2-2228-2050
• Email: JWHAN[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2028
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Pediatric Germ Cell Tumor

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate		12weeks
Secondary	Overall Response Rate		12 weeks and 18 weeks
Secondary	Complete Response Rate		18 weeks
Secondary	Overall Survival		3 years
Secondary	Event Free Survival		3 years