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Central Nervous System Nongerminomatous Germ Cell TumorCognitive functionChildren's healthCancerProcedureDrugBiologicalRadiationPhase 2

What this study is

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.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo collection of CSF and blood samples

  • Carboplatin

    Intervention · DRUG

  • Etoposide

    Intervention · DRUG

  • Filgrastim

    Intervention · BIOLOGICAL

    Given subcutaneously (SC) or IV

  • Ifosfamide

    Intervention · DRUG

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Mesna

    Intervention · DRUG

    Given IV or orally

  • Pegfilgrastim

    Intervention · BIOLOGICAL

    Given SC

  • Peripheral Blood Stem Cell Transplantation

    Intervention · PROCEDURE

    Undergo PBSC transplant

  • Questionnaire Administration

    Intervention · OTHER

    Ancillary studies

  • Radiation Therapy

    Intervention · RADIATION

    Undergo WVSCI radiation therapy

  • Radiation Therapy

    Intervention · RADIATION

    Undergo Craniospinal radiation therapy

  • Second-Look Surgery

    Intervention · PROCEDURE

    Undergo second-look surgery if needed

  • Thiotepa

    Intervention · DRUG

All of Carboplatin, Etoposide, Ifosfamide, Thiotepa

Given IV

Study details

Official title
A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor
Sponsor
Children's Oncology Group
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
Enrolling
160 people
Starts
2021-07-13
Est. completion
2029-12-21
Design
Open-label, non-randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗