A Phase II Study of Chemotherapy Followed by Radiation Therapy for Children and Young Adults with Localized Non-Germinomatous Germ Cell Tumors of the Brain or Spinal Cord

Share

Full Title

A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular and Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor (ACNS2021) (CIRB)

Purpose

Studies have shown that patients with newly diagnosed localized non-germinomatous germ cell tumors (NGGCT) of the brain or spinal cord whose disease responds well to chemotherapy before receiving radiation therapy are more likely to be free of the disease for a longer time than patients in whom chemotherapy is less effective.

In this study, researchers want to determine the best way to combine chemotherapy and radiation therapy in patients with NGGCT that have not spread, based on their responses to initial (“induction”) chemotherapy. 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.

Patients who respond well to induction chemotherapy will receive radiation therapy to the spine and a portion of the brain. Those who do not respond well to induction chemotherapy will receive high-dose chemotherapy and a stem cell transplant before radiation therapy to the whole brain and spine.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be newly diagnosed with localized primary NGGCT in the ventricles of the brain or spinal cord.
  • Patients may not have had any prior treatment for  NGGCT other than surgery and steroids.
  • This study is for patients ages 3-29.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

21-357

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04684368