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Title MSK 19-342 PROTECT: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields
Therapeutic Area Glioblastoma, Glioblastoma Multiforme
Principal Investigator Suriya Jeyapalan, MD
Min Age 18 Years
Gender Both
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This is a phase 2, multicenter, open-label study. Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin 1% and triamcinolone 0.1%. This study was designed to test the efficacy of topical clindamycin and triamcinolone for the prevention of moderate to severe skin toxicity from TTFields. 

Study Details

Inclusion Criteria

  • Age ≥18 years
  • Diagnosis of newly diagnosed 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
  •  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 dexamethasone 2mg a day or greater within 14 days of enrollment
  • Recurrent GBM or malignant glioma
  • Concurrent administration of bevacizumab
  • Pregnant Women

Study Requirements

The primary outcome of this study is to assess the incidence of grade ≥2 device-related skin
toxicities in patients treated with clindamycin plus triamcinolone, at study completion (day 90 ± 14
days). Clinical assessment at all study visits, including baseline CTCAE grading, will be performed
by a study investigator.

Bacterial cultures will be collected at baseline, the first follow up and the final assessment to identify
organisms with no sensitivity. Sensitivity should not be completed. Microbiologic results will be
reported as a descriptive variable. Bacterial culture results will be categorized as negative or
positive. For bacterial cultures, frequency distributions will be calculated and presented for each of
the treatment arms. For impedance results, numerical graphs will be used against a threshold.