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
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma
• Skin Toxicity

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

External Links

•   Memorial Sloan Kettering Cancer Center