Clinical trial NCT04469075: Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioblastoma
Recurrent Glioblastoma
Skin Toxicity
Keywords: Clindamycin
Triamcinolone
Skin-Related Side Effects
Recurrent
19-342
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a phase 2, multicenter, open-label study.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion 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.

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 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

Primary outcomes:
measure: Number of patients without grade 2 or higher skin toxicity
timeFrame: up to 120 days
Secondary outcomes:
measure: skin-related quality of life
timeFrame: up to 120 days
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Hauppauge
country: United States
facility: Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alina Markova, MD
role: PRINCIPAL_INVESTIGATOR
References: