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

• ClinicalTrials.gov Identifier: NCT04469075
• Recruitment Status: Recruiting
• First Posted: July 13, 2020
• Last Update Posted: February 9, 2023
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: July 10, 2020
• First Posted Date: July 13, 2020
• Last Update Posted Date: February 9, 2023
• Actual Study Start Date: July 9, 2020
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 10, 2020)

Number of patients without grade 2 or higher skin toxicity [ Time Frame: up to 120 days ]

device-related skin adverse events by investigator assessment.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 10, 2020)

skin-related quality of life [ Time Frame: up to 120 days ]

using the PRO-CTCAE for rash, ulcer, and pruritus.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is a phase 2, multicenter, open-label study.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Glioblastoma
• Recurrent Glioblastoma
• Skin Toxicity

Intervention

• Drug: Clindamycin Phosphate
  phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)
• Drug: Triamcinolone Acetonide
  triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change

Study Arms

Experimental: topical clindamycin and triamcinolone

Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval

Interventions:

• Drug: Clindamycin Phosphate
• Drug: Triamcinolone Acetonide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 10, 2020): 58
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Mario Lacouture, MD; 646-608-2337; lacoutum@mskcc.org

Contact: Alina Markova, MD; 646-608-2342

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04469075
• Other Study ID Numbers: 19-342
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

• Current Responsible Party: Memorial Sloan Kettering Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Memorial Sloan Kettering Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mario Lacouture, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: February 2023