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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.

Conditions

Pediatric Cancer, CNS Tumor, Childhood, Skin Inflammation

Recruitment Status

Recruiting

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 during treatment for brain tumors. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive a study treatment regimen that involves a daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study. Participants enrolled in this study, will be in this research study during the course of their anti-cancer treatment and receive skin examinations and complete a survey about their skin condition at the initial visit when anti-cancer treatment is started, at six weeks after the start of anti-cancer treatment, and at twelve weeks after the start of anti-cancer treatment. Participants will be followed for twelve weeks. It is expected that about 20 people will take part in this research study.

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

Intervention

Intervention Type

Intervention Name

Other

Warm Baths or Showers

Other

Moisturizer

Drug

SPF 30 or Higher Suncreen

Other

Sun Protective Clothing

Behavioral

Limited Sun Exposure

Other

Dilute bleach baths

Phase

Phase 2

Gender

All

Min Age

6 Months

Max Age

18 Years

Download Date

February 2, 2022

Principal Investigator

Jennifer Huang, MD

Primary Contact Information

Jennifer Huang, MD

617-355-1477

Jennifer.Huang@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: