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Trial record 1 of 1 for:    A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields
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Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469075
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Skin Toxicity Drug: Clindamycin Phosphate Drug: Triamcinolone Acetonide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
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
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
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023


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




Primary Outcome Measures :
  1. Number of patients without grade 2 or higher skin toxicity [ Time Frame: up to 120 days ]
    device-related skin adverse events by investigator assessment.


Secondary Outcome Measures :
  1. skin-related quality of life [ Time Frame: up to 120 days ]
    using the PRO-CTCAE for rash, ulcer, and pruritus.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of newly diagnosed 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 dexamethasone 2mg a day or greater within 14 days of enrollment
  • Recurrent GBM or malignant glioma
  • Concurrent administration of bevacizumab
  • Pregnant Women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469075


Contacts
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Contact: Mario Lacouture, MD 646-608-2337 lacoutum@mskcc.org
Contact: Alina Markova, MD 646-608-2342

Locations
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United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Priya Kumthekar, MD       p-kumthekar@northwestern.edu   
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Suriya L Jeyapalan, MD, MPH    617-636-6227      
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Milan Anadkat, MD    314-362-8180      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Mario Lacouture, MD    646-608-2337      
Contact: Alina Markova, MD    646-608-2342      
Principal Investigator: Mario Lacouture, MD         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Fabio Iwamoto, MD    212-342-0571      
United States, Ohio
University of Cincinnati Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Yehudit Rothman, PA    513-558-2968      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Mario Lacouture, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04469075    
Other Study ID Numbers: 19-342
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: December 2021
Individual Participant Data (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.

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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
Keywords provided by Memorial Sloan Kettering Cancer Center:
Clindamycin
Triamcinolone
Skin-Related Side Effects
19-342
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors