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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glioblastoma, Recurrent Glioblastoma, Skin Toxicity

Intervention / Treatment
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* Drug: Clindamycin Phosphate
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a phase 2, multicenter, open-label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: topical clindamycin and triamcinolone<br>Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval | Drug: Clindamycin Phosphate<br>* phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)<br>Drug: Triamcinolone Acetonide<br>* triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients without grade 2 or higher skin toxicity | device-related skin adverse events by investigator assessment. | up to 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin-related quality of life | using the PRO-CTCAE for rash, ulcer, and pruritus. | up to 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clindamycin, Triamcinolone, Skin-Related Side Effects, Recurrent, 19-342