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NCT04469075 Clinical Trial

Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

Glioblastoma Clinical Trial

Official title:
The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04469075
Other study ID # 19-342
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 9, 2020
Est. completion date July 2025

Study information
Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Alina Markova, MD
Phone 646-608-2342
Email markovaa@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The participants are being treated with Tumor Treating Fields (TTFields) for malignant glioma, and this type of treatment may cause skin-related side effects. This study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of TTFields.

Recruitment information / eligibility
Status Recruiting
Enrollment 58
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years - Diagnosis of newly diagnosed or recurrent GBM with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution - Able to self-administer topical interventions or has available another person who can apply the topical agents - Treatment with TTF should be initiated within 7 days of planned initiation on this trial. Exclusion Criteria: - Known history of allergy to any ingredient of the study agents - Preexisting scalp disorders such as psoriasis or dermatitis that, in the opinion of the investigator, will affect the grading of skin adverse events, confirmed by enrolling institution. - Use of concurrent topical therapy to the scalp for another dermatologic condition - Active, uncontrolled infection requiring systemic or oral antibiotic therapy within 14 days of enrollment - Use of greater than 4 mg dexamethasone a day within 14 days of enrollment - Malignant glioma - Pregnant Women

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Clindamycin Phosphate
phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)
• Triamcinolone Acetonide
triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change

Locations
Country Name City State
United States Tufts Medical Center Boston Massachusetts
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Northwestern University Evanston Illinois
United States Hackensack Meridian Health Hackensack New Jersey
United States Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities) Hauppauge New York
United States Columbia University New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients without grade 2 or higher skin toxicity device-related skin adverse events by investigator assessment. up to 120 days
Secondary skin-related quality of life using the PRO-CTCAE for rash, ulcer, and pruritus. up to 120 days
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