What is this study of chemotherapy and radiation therapy trying to find out about localized NGGCT?

This study evaluates how well tumors respond to initial chemotherapy to guide subsequent treatment for localized non-germinomatous germ cell tumors in the brain. It aims to reduce spinal relapses and adjust therapy intensity based on tumor response. The Children's Oncology Group sponsors this research to improve treatment outcomes and lessen side effects.

Who may be eligible for this localized NGGCT clinical trial?

Participants aged 3 to 29 years with newly diagnosed localized non-germinomatous germ cell tumors in the brain's suprasellar or pineal region may be eligible. Both males and females can join if they meet specific health and laboratory criteria and have not received prior tumor-directed treatment beyond surgery or steroids. Please review eligibility criteria for more details.

Is there any cost to participate in this localized NGGCT clinical trial?

Study-related care, including the chemotherapy, radiation therapy, and all trial visits, is provided at no cost. Personal travel and accommodation expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 3Years - 29Years

All Genders

ID04684368

A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular Spinal Canal Irradiation for Patients With Localized Non-Germinomatous CNS Germ Cell Tumor

Led by Children's Oncology Group · Updated on 2026-05-05

160

Participants Needed

166

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the best way to combine chemotherapy and radiation therapy for patients aged 3 to 29 years with localized non-germinomatous germ cell tumors NGGCT in the brain. This phase II trial aims to optimize treatment based on how well the tumor responds to initial chemotherapy, with the goal of reducing spinal cord relapses and adjusting therapy for better disease control. The study also compares different radiation types and examines cognitive and physical effects in children and young adults with NGGCT. Participants first receive induction chemotherapy consisting of carboplatin, etoposide, and ifosfamide over six cycles every 21 days. Based on tumor response, patients are assigned to one of two plans Plan A involves whole ventricular plus spinal canal irradiation WVSCI, delivered daily for 6 weeks, while Plan B includes high-dose chemotherapy with stem cell transplant followed by radiation therapy to the whole brain and spine. Some patients may undergo second-look surgery depending on tumor response before continuing treatment. Throughout the study, participants undergo MRI scans, collection of cerebrospinal fluid and blood samples, and questionnaires assessing cognitive, social, and behavioral functioning. Researchers monitor tumor response, progression-free survival, overall survival, and patterns of disease recurrence for up to 10 years. Safety and side effects are also evaluated to better understand long-term outcomes of these treatment approaches.

CONDITIONS

Brief Title

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

Who Can Participate

Age: 3Years - 29Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients aged 3 years to less than 30 years at enrollment
Newly diagnosed with localized primary CNS non-germinomatous germ cell tumor in suprasellar and/or pineal region confirmed by pathology or elevated tumor markers
Cranial MRI with and without gadolinium at diagnosis and spine MRI with gadolinium prior to enrollment
Lumbar cerebrospinal fluid obtained prior to enrollment unless medically contraindicated
Peripheral blood counts and kidney and liver function tests within specified normal limits prior to enrollment
Patients with controlled seizure disorder may enroll
Protocol therapy must begin within 31 days of definitive surgery or clinical diagnosis
English, Spanish, or French speaking for neurocognitive and quality of life assessments
No known history of neurodevelopmental disorders prior to tumor diagnosis
Informed consent signed by patient or guardian
Compliance with all institutional and regulatory requirements for human studies

You will not qualify if you...

Tumors located outside brain ventricles (e.g., basal ganglia, thalamus)
Only mature teratoma present and non-elevated tumor markers
Prior tumor-directed therapy other than surgery or corticosteroids
Metastatic disease detected by imaging or cerebrospinal fluid cytology
Pregnant females
Lactating females who plan to breastfeed
Sexually active patients of reproductive potential not agreeing to effective contraception during study participation

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