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Chemotherapy Followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Short Title: ANCS2021


Enrollment Status: Recruiting

NCT #: NCT04684368

Specialty Area: Pediatric Hematology/Oncology

Condition Studied: Non-Germinomatous Central Nervous System Germ Cell Tumor

Age Groups: Child; Adult

Phase: II


Study Information

Summary / Purpose

The purpose of this study is to identify 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).

Study Type: Interventional

Who Can Participate

Eligibility Criteria:
  • Children and Adults 3 - 30 years of age
  • Suspected of having newly diagnosed localized CNS NGGCT
  • Must have adequate bone marrow, renal, and liver function

What's Involved

Participation in the study will include:
  • Induction chemotherapy, the first phase of treatment, which may include carboplatin, etoposide, and ifosfamide
  • Magnetic resonance imaging (MRI) scans to check how the tumor responds to induction chemotherapy and decide the next phase of treatment
  • Surgery to remove any tumor that remains after induction chemotherapy, if needed
  • For participants whose tumors respond well, radiation therapy to the spine and part of the brain
  • For participants whose tumors do not respond well, high-dose chemotherapy with thiotepa and a stem cell transplant using your own blood stem cells, followed by radiation therapy to the whole brain and spine
  • Medicines to help protect the body during chemotherapy, including drugs that support blood cell recovery (filgrastim or pegfilgrastim) and a drug that protects the bladder (mesna)
  • Sample collection for research
  • Completing questionnaires

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.