A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
This study is looking for children and young adults, aged 3 to 29, who have a specific type of brain tumor called non-germinomatous germ cell tumor (NGGCT) that has not spread. The goal is to find the best way to combine chemotherapy and radiation therapy. Researchers will use drugs like carboplatin, etoposide, ifosfamide, and filgrastim. They want to see if they can reduce the rate of the tumor coming back in the spine, especially for those who respond well to initial chemotherapy. For those who don't respond as well, they will try higher doses of chemotherapy. Success will be measured by how many patients have the tumor return within two years of joining the study. The current status of this study is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 160 participants.
- What's involved
- Participants will undergo collection of cerebrospinal fluid (CSF) and blood samples. They will receive chemotherapy drugs (carboplatin, etoposide, ifosfamide) intravenously and filgrastim subcutaneously or intravenously.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure failure rates and spinal failure rates within two years of enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04684368
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Recruiting
PHASE2Ages 3–29InterventionalTreatmentChildren's Oncology GroupGovernment-funded
~160 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCarboplatinEtoposideFilgrastimIfosfamideMagnetic Resonance Imaging
At a glance
Recruiting sites
159 of 170 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Failure rate
Measured over Within 2 years of enrollment
+1 more outcome measured
Conditions
Where it's being run
170 sites across 60 statesCalifornia12
New York12
Texas12
Florida11
Ohio8
Michigan6
New Jersey6
Illinois5
Study leadership
- Shannon M MacDonald · PRINCIPAL_INVESTIGATOR · Children's Oncology Group
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must be \>= 3 years and \< 30 years at the time of study enrollment
Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or \> 10 ng/mL or human chorionic gonadotropin (hCG) beta \> 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy \[repeat if necessary\]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy \[repeat if necessary\]). Basal ganglia or other primary sites are excluded
Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)
Patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy )
Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy)
Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery
Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first
Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment)
Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) (within 7 days prior to enrollment)
Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
Age: Maximum serum creatinine (mg/dL)
3 to \< 6 years: 0.8 (male), 0.8 (female)
6 to \< 10 years: 1 (male), 1 (female)
10 to \< 13 years: 1.2 (male), 1.2 (female)
13 to \< 16 years: 1.5 (male), 1.4 (female)
\>= 16 years: male (1.7), 1.4 (female)
Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment)
Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
Central nervous system function defined as:
Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment
Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT:
English-, Spanish-, or French- speaking
Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments
No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate
Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery
Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires
Exclusion
Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)
Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)
Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs
Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
What this trial measures
- Failure rateWithin 2 years of enrollment
Will be measured by the number of progressions or deaths within 2 years of enrollment for the cohort treated with whole ventricular + spinal canal irradiation (WVSCI). The final analysis will include an exact binomial confidence interval of the failure rate for each of the failure types (local, distant/spinal or both) without adjustment for multiplicity.
- Spinal failure rateWithin 2 years of enrollment
Will be measured by the number of spinal relapses (spine alone or distant relapses including the spine) within 2 years of enrollment in patients treated with WVSCI. The final analysis will include an exact binomial confidence interval of spinal failure rate.