Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

Description

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.

Conditions

Glioblastoma, Recurrent Glioblastoma, Skin Toxicity

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Study Overview

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Study Details

Study overview

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.

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

Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

Condition
Glioblastoma
Intervention / Treatment

-

Contacts and Locations

Evanston

Northwestern University, Evanston, Illinois, United States, 60208

Boston

Tufts Medical Center, Boston, Massachusetts, United States, 02111

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Hackensack

Hackensack Meridian Health, Hackensack, New Jersey, United States, 07601

Hauppauge

Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities), Hauppauge, New York, United States, 11788

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10021

New York

Columbia University, New York, New York, United States, 10032

Cincinnati

University of Cincinnati Medical Center, Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Alina Markova, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2025-07