Chemotherapy using Paclitaxel, Ifosfamide, and Cisplatin for high-risk pediatric germ cell tumors
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
This study is testing a new chemotherapy combination for kids and young adults with high-risk germ cell tumors to see if it helps them live longer and have fewer side effects than standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 1 Year to 20 Years |
| Sex | Male |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05455918 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a chemotherapy regimen consisting of paclitaxel, ifosfamide, and cisplatin (TIP) as a first-line treatment for high-risk pediatric germ cell tumors. The study focuses on patients aged 1 to 20 years with untreated germ cell tumors that are classified as stage II or higher. The TIP regimen aims to improve survival rates while reducing lung toxicity compared to standard treatments. The trial will assess the outcomes of this approach in a population known to have poor prognoses.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 20 years with untreated high-risk germ cell tumors at stage II or higher.
Not a fit: Patients with previously treated germ cell tumors or those with certain allergies to the chemotherapy agents will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for children with high-risk germ cell tumors.
How similar studies have performed: There is some promising evidence from previous studies regarding the TIP regimen, but this specific application in high-risk pediatric patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Jung Woo Han — Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.
- Study coordinator: Jung Woo Han
- Email: JWHAN@yuhs.ac
- Phone: 82-2-2228-2050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.