The PROTECT Study: A phase II, open-label trial of prophylactic skin toxicity therapy with clindamycin and triamcinolone in patients with glioblastoma treated with tumor-treating fields.
Authors: Lacouture Mario E. , Ketosugbo Kwami , Dusza Stephen W , Goldlust Samuel A. , Kumthekar Priya , Iwamoto Fabio Massaiti 
Published: June 2022

TPS2084

Background: Glioblastoma Multiforme (GBM), is the most common and aggressive brain tumor. Tumor Treatment Fields (TTFields) is a noninvasive, regional antimitotic treatment modality approved for the treatment of recurrent and newly diagnosed GBM by the US Food and Drug Administration. TTFields delivers low intensity (1-3 V/cm), intermediate frequency (100-300 kHz), alternating electric fields to the tumor through noninvasive transducer arrays placed on the skin, around the region of the body containing the tumor. During mitosis, TTFields disrupt the formation of the mitotic spindle during metaphase resulting in apoptosis. Dermatologic adverse events (AEs) to TTFields include dermatitis and infections and were reported in 54% of patients in a phase III trial. Topical triamcinolone and clindamycin have demonstrated anecdotal benefit because of their anti-inflammatory and antimicrobial activity. Pre-clinical studies have shown no negative effect on impedance when applied onto skin under the arrays. The effect of topical triamcinolone and clindamycin for the prevention of skin AEs to TTFields has not been studied prospectively. Methods: We are conducting a phase II multicenter clinical trial in patients receiving standard-of-care TTFields therapy for GBM to determine the efficacy of a prophylactic intervention: topical clindamycin 1% solution and triamcinolone 0.1% lotion in preventing grade ≥2 epicutaneous device-related events. Eligible patients must be ≥18 years of age, newly diagnosed with GBM and initiating TTFields within 7 days of study enrollment. The primary objective is to determine the effect of topical clindamycin 1% and triamcinolone 0.1% on the prevention of grade ≥2 device-related skin AEs. Secondary objectives include investigating the effect of study agents on skin-related quality of life (using the PRO-CTCAE modules for rash, ulcer, and pruritus), evaluating the efficacy of study agents applied to the scalp at every array change by standardized photography evaluated by a blinded investigator, measuring the duration of skin toxicities and usage of the TTFields device, measuring the duration of treatment interruptions and time to first grade ≥ 2 skin events, determining the bacterial flora of scalp infections, and determining the effect of study agents on TTFields’ impedance. Patients will be on study for 90 days. An end-of-study assessment will occur on day 90, and a post-treatment visit will occur on day 120. The first patient was enrolled on October 21, 2020 and hitherto, 8 patients have been consented. Participating sites include Memorial Sloan Kettering Cancer Center, Columbia University Medical Center, Tufts University Medical Center, Northwestern University, Washington University, University of Cincinnati, and John Theurer Cancer Center - Hackensack Meridian Health. Clinical trial information: NCT04469075.