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

Primary Purpose

Glioblastoma, Recurrent Glioblastoma, Skin Toxicity

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clindamycin Phosphate
Triamcinolone Acetonide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Clindamycin, Triamcinolone, Skin-Related Side Effects, Recurrent, 19-342

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting
  • Tufts Medical CenterRecruiting
  • Washington University School of MedicineRecruiting
  • Hackensack Meridian HealthRecruiting
  • Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Columbia University
  • University of Cincinnati Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

topical clindamycin and triamcinolone

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patients without grade 2 or higher skin toxicity
device-related skin adverse events by investigator assessment.

Secondary Outcome Measures

skin-related quality of life
using the PRO-CTCAE for rash, ulcer, and pruritus.

Full Information

First Posted
July 10, 2020
Last Updated
February 7, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04469075
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Recurrent Glioblastoma, Skin Toxicity
Keywords
Clindamycin, Triamcinolone, Skin-Related Side Effects, Recurrent, 19-342

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a phase 2, multicenter, open-label study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
topical clindamycin and triamcinolone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Clindamycin Phosphate
Intervention Description
phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change
Primary Outcome Measure Information:
Title
Number of patients without grade 2 or higher skin toxicity
Description
device-related skin adverse events by investigator assessment.
Time Frame
up to 120 days
Secondary Outcome Measure Information:
Title
skin-related quality of life
Description
using the PRO-CTCAE for rash, ulcer, and pruritus.
Time Frame
up to 120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Lacouture, MD
Phone
646-608-2337
Email
lacoutum@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alina Markova, MD
Phone
646-608-2342
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Lacouture, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priya Kumthekar, MD
Email
p-kumthekar@northwestern.edu
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suriya L Jeyapalan, MD, MPH
Phone
617-636-6227
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milan Anadkat, MD
Phone
314-362-8180
Facility Name
Hackensack Meridian Health
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Goldlust, MD
Phone
551-996-5266
Facility Name
Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities)
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Lacouture, MD
Phone
646-608-2337
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Lacouture, MD
Phone
646-608-2337
First Name & Middle Initial & Last Name & Degree
Alina Markova, MD
Phone
646-608-2342
First Name & Middle Initial & Last Name & Degree
Mario Lacouture, MD
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yehudit Rothman, PA
Phone
513-558-2968

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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