This phase II trial studies how well clindamycin and triamcinolone work in preventing skin-related side effects of tumor treating fields (TTFields) in patients with glioblastoma or any malignant glioma. Clindamycin is an antibiotic that works by slowing or stopping the growth of bacteria and used to prevent or treat skin infection. Triamcinolone is a corticosteroid that works by copying the effects of hormones that the body makes naturally to prevent inflammation and used to reduce swelling, itching, and redness of the skin. The TTFields device uses low-intensity electrical fields to treat cancer, and this type of therapy can cause skin side effects, such as itching, sores, or infections. Using clindamycin and triamcinolone topical (on the skin) lotions before these side effects occur may be able to prevent their appearance, so that TTFields can be used with less need for interruptions.
Additional locations may be listed on ClinicalTrials.gov for NCT04469075.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Determine the effect of topical clindamycin 1% (or approved equivalent) and triamcinolone 0.1% on the prevention of grade >= 2 device-related skin adverse events by investigator assessment.
SECONDARY OBJECTIVES:
I. Determine the effect of topical clindamycin 1% (or approved equivalent) and triamcinolone 0.1% on skin-related quality of life using the Patient Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) for rash, ulcer, and pruritus.
II. Evaluate the efficacy of topical clindamycin 1% (or approved equivalent) and triamcinolone 0.1% applied to the scalp at every array change by standardized photography evaluated by a blinded investigator.
III. Measure the duration of skin toxicities experienced by patients and the duration patients use the TTFields device.
IV. Measure the duration of treatment interruptions and time to first grade >= 2 skin events.
V. Determine the bacterial flora of scalp infections.
VI. Determine the effect of topical clindamycin 1% (or approved equivalent) and triamcinolone 0.1% on TTField impedance.
OUTLINE:
Every 3-4 days at the time of array repositioning, following shaving and cleaning of the scalp, patients apply a thin layer of clindamycin phosphate gel (or approved equivalent), massage it into the scalp, and allow it to dry for 5 minutes. Patients then apply a thin layer of triamcinolone acetonide lotion and massage it into the scalp. After 5-30 minutes, once the scalp is completely dry, the transducer arrays are then affixed to the scalp and the TTFields therapy resumes. Treatment with clindamycin phosphate and triamcinolone acetonide continues for 90 days at every array change in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 30 days.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAlina Markova
