OncoMatch/Clinical Trials/NCT04684368
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Official title: A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor
Is NCT04684368 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for central nervous system nongerminomatous germ cell tumor.
Treatment: Carboplatin · Etoposide · Filgrastim · Ifosfamide · Mesna · Pegfilgrastim · Thiotepa — This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Glioblastoma
Testicular Germ Cell Tumor
Biomarker criteria
Required: AFP elevation (above institutional normal or > 10 ng/mL)
serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or > 10 ng/mL
Required: CGB elevation (> 100 mIU/mL)
human chorionic gonadotropin (hCG) beta > 100 mIU/mL
Disease stage
Excluded: Stage IV
Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination) [excluded]
Demographics
Prior therapy
Cannot have received: tumor-directed therapy for NGGCT (other than surgical intervention and corticosteroids)
Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
Lab requirements
Blood counts
ANC ≥ 1000/uL; Platelet count ≥ 100,000/uL (transfusion independent); Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m^2 or age/sex-based serum creatinine
Liver function
Total bilirubin ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 135 U/L (ULN for SGPT (ALT) set to 45 U/L)
Peripheral absolute neutrophil count (ANC) ≥ 1000/uL; Platelet count ≥ 100,000/uL (transfusion independent); Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions); Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2 or a serum creatinine based on age/sex; Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135 U/L (ULN for SGPT (ALT) set to 45 U/L)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- Providence Alaska Medical Center · Anchorage, Alaska
- Banner Children's at Desert · Mesa, Arizona
- Phoenix Childrens Hospital · Phoenix, Arizona
- Banner University Medical Center - Tucson · Tucson, Arizona
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04684368 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tumor-directed therapy for NGGCT (other than surgical intervention and corticosteroids) disqualifies patients from enrollment.
Does this trial require AFP?
Yes, AFP elevation is a required biomarker for enrollment.
Does this trial require CGB?
Yes, CGB elevation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 29 years or younger and at least 3 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages