NCT04684368 · Children's Oncology Group
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
What this study is about
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).
View original scientific description
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).
Interventions
PROCEDURE
Biospecimen Collection
Undergo collection of CSF and blood samples
DRUG
Carboplatin
Given IV
DRUG
Etoposide
Given IV
BIOLOGICAL
Filgrastim
Given subcutaneously (SC) or IV
DRUG
Ifosfamide
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
DRUG
Mesna
Given IV or orally
BIOLOGICAL
Pegfilgrastim
Given SC
PROCEDURE
Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplant
OTHER
Questionnaire Administration
Ancillary studies
RADIATION
Radiation Therapy
Undergo WVSCI radiation therapy
RADIATION
Radiation Therapy
Undergo radiation therapy
PROCEDURE
Second-Look Surgery
Undergo second-look surgery if needed
DRUG
Thiotepa
Given IV
Primary outcome measures
Failure rate
Time frame: Within 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 rate
Time frame: Within 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Birmingham, Alabama
- Anchorage, Alaska
- Mesa, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Downey, California
- Loma Linda, California
- Long Beach, California
- Los Angeles, California
- Madera, California
- Oakland, California
And 110 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations