A Phase II Study of Clindamycin and Triamcinolone in People with Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

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Full 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

Purpose

Tumor treating fields (TTFields) are a form of treatment for a brain cancer called glioblastoma in which mild electrical fields pulse through the skin of the scalp to inhibit the ability of cancer cells to divide. However, this type of therapy can cause skin side effects such as itching, sores, and infections. Researchers want to know if using clindamycin and triamcinolone lotions can prevent these side effects, enabling patients to continue TTFields therapy without interruption.

Clindamycin is an antibiotic. Triamcinolone is a corticosteroid that prevents inflammation and itching. Patients in this study will periodically apply clindamycin and triamcinolone before reapplying the TTFields device to the scalp.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed glioblastoma and be planning to start TTFields therapy.
  • Patients may not have preexisting scalp disorders such as psoriasis or dermatitis.
  • This study is for patients age 18 and older.

 

Contact

For more information and to see if you can join this study, please contact Dr. Alina Markova’s office at 646-608-2342.

Protocol

19-342

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04469075