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

Conditions

• Central Nervous System Nongerminomatous Germ Cell Tumor
• Choriocarcinoma
• Embryonal Carcinoma
• Immature Teratoma
• Malignant Teratoma
• Mixed Germ Cell Tumor
• Pineal Region Germ Cell Tumor
• Pineal Region Immature Teratoma
• Pineal Region Yolk Sac Tumor
• Suprasellar Germ Cell Tumor

Eligibility Criteria

Sex

ALL

Age

3 Years - 29 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of CSF and blood samples
• Carboplatin — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Filgrastim — BIOLOGICAL
  Given subcutaneously (SC) or IV
• Ifosfamide — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Mesna — DRUG
  Given IV or orally
• Pegfilgrastim — BIOLOGICAL
  Given SC
• Peripheral Blood Stem Cell Transplantation — PROCEDURE
  Undergo PBSC transplant
• Questionnaire Administration — OTHER
  Ancillary studies
• Radiation Therapy — RADIATION
  Undergo WVSCI radiation therapy
• Radiation Therapy — RADIATION
  Undergo radiation therapy
• Second-Look Surgery — PROCEDURE
  Undergo second-look surgery if needed
• Thiotepa — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Jul 13, 2021

Status verified

Jan 2026

Primary completion

Dec 21, 2029

Completion

Dec 21, 2029

Study Design

Enrollment

160 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Plan A (chemotherapy, WVSCI, second-look surgery if needed)
  See Outline in Detailed Description.
• Experimental: Plan B (chemotherapy, HDCSCR, second-look surgery if needed)
  See Outline in Detailed Description.

Primary Outcome Measure

Failure rate [ Time Frame: Within 2 years of enrollment ]

Locations (149)

Find similar trials in Birmingham, AL

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• Molecular Epidemiology of Pediatric Germ Cell Tumors
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