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

Summary

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.

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Shannon M MacDonald · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-13

Primary Completion

2029-12-21

Completion

2029-12-21

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• New Zealand

Study Locations