Study on a New Treatment Approach for Children and Young Adults with a Brain Tumor Called NGGCT

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04684368

Provider View

This clinical trial is exploring a new way to treat children and young adults with a specific type of brain tumor called non-germinomatous germ cell tumors (NGGCT). The study aims to find the best combination of chemotherapy and radiation therapy based on how well the tumor responds to initial chemotherapy.

Patient Parameters

Program Overview

This study is testing a new treatment plan for children and young adults with a type of brain tumor called non-germinomatous germ cell tumors (NGGCT) that hasn't spread to other parts of the brain or body. The study has two main goals: 1) to adjust radiation therapy for patients who respond well to initial chemotherapy to reduce the chance of the cancer coming back in the spinal cord, and 2) to use higher doses of chemotherapy followed by regular radiation for patients who don't respond well to initial chemotherapy. Chemotherapy drugs work by stopping tumor cells from growing, dividing, or spreading, while radiation therapy uses high-energy rays to kill tumor cells. The study will help decide the next steps in treatment based on how the tumor responds to the initial chemotherapy, aiming to reduce side effects and improve treatment effectiveness.

Description

Primary Objectives:

  • To ensure that children and young adults with localized NGGCT who respond well to initial chemotherapy and receive radiation to the brain and spine maintain a high rate of being free from disease for two years.
  • To reduce the number of cancer recurrences in the spine for patients who respond well to initial chemotherapy and receive radiation to the brain and spine.

Secondary Objectives:

  • To estimate how well patients respond to initial chemotherapy and radiation.
  • To estimate the time patients remain free from disease and their overall survival.
  • To estimate the response rate for patients who receive high-dose chemotherapy and stem cell rescue.

Exploratory Objectives:

  • To compare outcomes based on different types of radiation, including effects on cognitive and social functioning.
  • To compare growth and blood cell counts after radiation.
  • To evaluate the benefits of additional surgery.
  • To assess cognitive and social functioning over time.
  • To evaluate patterns of disease recurrence.

Treatment Plan:

  • Induction Chemotherapy: Patients receive chemotherapy drugs in cycles over several weeks. The treatment is repeated for up to six cycles unless the disease progresses or side effects become unacceptable.
  • Treatment Plans Based on Response:
    • Plan A (Radiation Therapy): Patients who respond well to chemotherapy receive radiation to the brain and spine.
    • Plan B (High-Dose Chemotherapy and Stem Cell Rescue): Patients who do not respond well to chemotherapy receive high-dose chemotherapy and a stem cell transplant, followed by radiation.

Patients will also undergo MRI scans and provide blood and spinal fluid samples throughout the study. After completing the treatment, patients will be followed for up to 10 years.

Eligibility Criteria

Inclusion Criteria

  • Aged between 3 and 30 years.
  • Newly diagnosed with localized NGGCT in specific brain regions.
  • Have certain tumor markers in blood or spinal fluid.
  • Have specific types of tumor cells.
  • Have MRI scans of the brain and spine.
  • Have certain blood counts and organ function levels.
  • Able to start treatment within 31 days of surgery or diagnosis.
  • Agree to participate and provide informed consent.
  • Speak English, Spanish, or French for certain assessments.
  • No history of certain developmental disorders.
  • Meet additional criteria for neuropsychological assessments.

Exclusion Criteria

  • Tumors located outside specific brain regions.
  • Only have mature teratoma with non-elevated markers.
  • Have received prior tumor-directed therapy other than surgery and steroids.
  • Have metastatic disease.
  • Pregnant or breastfeeding females.
  • Sexually active patients not using effective contraception.

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