Status:
COMPLETED
Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Pediatric Cancer
CNS Tumor, Childhood
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
This research study is examining a preventive skin care regimen for children diagnosed with a brain tumor and receiving anti-cancer therapy with a MEK, Pan-RAF, or BRAF inhibitor.
Detailed Description
This prospective, single-arm phase 2 clinical trial is looking at whether gentle skin care, sun protection and dilute bleach baths might decrease the chances or the severity of skin changes that occur...
Eligibility Criteria
Inclusion
- Diagnosed with a brain tumor between ages 6 months old -18 years old and will undergo treatment with at least one of the following:
- Targeted BRAF inhibitor therapy to treat the brain tumor
- Targeted MEK inhibitor therapy to treat the brain tumor
- Targeted pan-RAF inhibitor therapy to treat the brain tumor
- Subjects may participate in other studies, including therapeutic trials.
- Ability to comply with PSCR including sun protection, gentle skin care and every other day dilute bleach baths.
- Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.
Exclusion
- Diagnosed with brain tumor at \> 18 years old
- No data in medical records regarding treatment exposures
- Treated with a BRAF, MEK or pan-RAF inhibitor in the last three months
- Past or present allergic reaction to bleach
- Past or present allergic reactions to sunscreen and/or creams, lotions, emollients to be utilized in this study
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04479514
Start Date
October 1 2020
End Date
February 15 2025
Last Update
May 1 2025
Active Locations (2)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215