ACTIVE_NOT_RECRUITING

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

Conditions

Glioblastoma Recurrent Glioblastoma Skin Toxicity Clindamycin Triamcinolone Skin-Related Side Effects Recurrent 19-342

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2020-07-09

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04469075

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Alina Markova, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Northwestern University

Evanston, Illinois, 60208

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Hackensack Meridian Health

Hackensack, New Jersey, 07601

United States

Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities)

Hauppauge, New York, 11788

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

United States

Columbia University

New York, New York, 10032

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-09

Study Completion Date2026-07

Study Record Updates

Study Start Date2020-07-09

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

Clindamycin
Triamcinolone
Skin-Related Side Effects
Recurrent
19-342

Additional Relevant MeSH Terms

Glioblastoma
Recurrent Glioblastoma
Skin Toxicity