Study on Reduced Radiation and Chemotherapy for Young Patients with Newly Diagnosed WNT-Driven Medulloblastoma
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT02724579
This clinical trial is exploring whether lower doses of radiation and chemotherapy can effectively treat young patients with a specific type of brain tumor called WNT-driven medulloblastoma, while reducing long-term side effects.
Patient Parameters
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Program Overview
This study is testing if using lower doses of radiation to the brain and spine, along with chemotherapy, can effectively treat children and young adults with a newly diagnosed type of brain tumor known as WNT-driven medulloblastoma. The goal is to kill cancer cells while minimizing long-term side effects like learning difficulties and hormonal issues. Radiation therapy uses high-energy rays to target cancer cells, and chemotherapy drugs like cisplatin and vincristine work to stop cancer cells from growing and spreading. By reducing the radiation and chemotherapy doses, the study aims to maintain treatment effectiveness while reducing potential side effects.
Description
The main goal of this study is to see how well children aged 3 and older with WNT-driven medulloblastoma respond to lower doses of radiation and chemotherapy. The study will monitor how long patients remain free from cancer progression. Secondary goals include understanding how the treatment affects patients' cognitive and emotional well-being over time.
Participants will start radiation therapy 4-5 weeks after surgery, receiving it 5 days a week for 6 weeks. After radiation, they will begin maintenance therapy with chemotherapy drugs like lomustine, vincristine, and cisplatin, given in cycles every 42 days. Additional chemotherapy with cyclophosphamide and mesna will be given in cycles every 28 days. Throughout the study, patients will have regular MRI scans to monitor their progress.
After completing the treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for another 2 years, and annually for 6 years to check on their health and any long-term effects.
Eligibility Criteria
Inclusion Criteria
- Age between 3 and 22 years old.
- Newly diagnosed with WNT-driven medulloblastoma, confirmed by specific tests.
- No cancer spread to the brain or spine, confirmed by MRI and spinal fluid tests.
- Surgery completed no more than 36 days before starting the study treatment.
- Adequate blood cell counts and organ function, as determined by specific medical tests.
- Ability to understand and speak English, French, or Spanish for certain assessments.
- Signed informed consent from patients and/or their guardians.
Exclusion Criteria
- Cancer has spread to the brain or spine.
- Previous radiation or chemotherapy treatment, except for surgery or steroids.
- Pregnant or breastfeeding women are not eligible.
- Patients with moderate to severe intellectual disabilities are not eligible, but those with ADHD or learning disabilities can participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| USA Health Strada Patient Care Center | 36604 | Mobile | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Miller Children's and Women's Hospital Long Beach | 90806 | Long Beach | California |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
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