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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma; Recurrent Glioblastoma; Skin Toxicity
• Intervention / Treatment: Drug: Clindamycin Phosphate; Drug: Triamcinolone Acetonide

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alina Markova, MD; Phone Number: 646-608-2342; Email: markovaa@mskcc.org
• Study Contact Backup: Name: Rashek Kazi, MD,PhD; Email: kazir@mskcc.org

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Recruiting
      • Northwestern University
      • Contact: Priya Kumthekar, MD; Email: p-kumthekar@northwestern.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Active, not recruiting
      • Tufts Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack Meridian Health
      • Contact: Deric M Park, MD, FACP; Phone Number: 844-301-4158
  • New York
    • Hauppauge, New York, United States, 11788
      • Recruiting
      • Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities)
      • Contact: Alina Markova, MD; Phone Number: 646-608-2342
    • New York, New York, United States, 10021
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Alina Markova, MD; Phone Number: 646-608-2342
      • Principal Investigator: Alina Markova, MD
      • Contact: Rashek Kazi, MD, PhD; Email: kazir@mskcc.org
    • New York, New York, United States, 10032
      • Active, not recruiting
      • Columbia University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Active, not recruiting
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients without grade 2 or higher skin toxicity	device-related skin adverse events by investigator assessment.	up to 120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin-related quality of life	using the PRO-CTCAE for rash, ulcer, and pruritus.	up to 120 days

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Alina Markova, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Estimated): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Triamcinolone; Recurrent; Clindamycin; Skin-Related Side Effects; 19-342
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Triamcinolone; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 19-342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• 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