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

Launched by YONSEI UNIVERSITY · Jul 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new chemotherapy treatment called the TIP regimen (which includes paclitaxel, ifosfamide, and cisplatin) for children and young adults with high-risk germ cell tumors. Germ cell tumors are a type of cancer that typically have a good outlook, but those classified as high-risk can be much more challenging to treat. The TIP regimen is being studied to see if it can improve survival rates while also reducing side effects, particularly lung damage that can occur with standard treatments.

To participate in the trial, patients must be between 1 and 19 years old and have a diagnosed germ cell tumor that has not been treated before. They should also have a higher stage of cancer, specifically stages II or higher. Key groups that may be eligible include children over 11 years old or younger children with specific types of high-risk tumors. Participants will receive the TIP treatment and will be monitored for both its effectiveness and any side effects. The trial is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if it’s a suitable option for them.

Gender

MALE

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