Phase 2
N=14
Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy
Pediatric Cancer · CNS Tumor, Childhood · Skin Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT04479514 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Rate of Cutaneous Reaction — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Warm Baths or Showers (Other); Moisturizer (Other); SPF 30 or Higher Suncreen (Drug); Sun Protective Clothing (Other); Limited Sun Exposure (Behavioral); Dilute bleach baths (Other)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Cutaneous Reaction |
7 | — |
| SECONDARY Overall Cutaneous Reaction Severity |
— | — |
| SECONDARY Xerosis Severity |
— | — |
| SECONDARY Hand Foot Syndrome Severity |
— | — |
| SECONDARY Pediatric Quality of Life |
— | — |
| SECONDARY Children's Dermatology Quality of Life |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04479514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.