GlioblastomaPhase 2NCT04469075
Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields
A Phase 2 study testing Clindamycin Phosphate and Triamcinolone Acetonide in people with Glioblastoma and Recurrent Glioblastoma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Recurrent Glioblastoma, Skin Toxicity
- What is being tested?
- Clindamycin Phosphate and Triamcinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- 9 Jul 2020to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Tufts Medical Center
Boston, Massachusetts, 02111
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Northwestern University
Evanston, Illinois, 60208
Hackensack Meridian Health
Hackensack, New Jersey, 07601
Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities)
Hauppauge, New York, 11788
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Columbia University
New York, New York, 10032
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
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.
- Conditions
- Glioblastoma, Recurrent Glioblastoma, Skin Toxicity
- Being tested
- Clindamycin Phosphate, Triamcinolone Acetonide
- Keywords
- Clindamycin, Triamcinolone, Skin-Related Side Effects, Recurrent, 19-342
- Medical subject headings
- Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin PhosphateDrug
phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)
Triamcinolone AcetonideDrug
triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change
| Study group | Role | What they receive |
|---|---|---|
| topical clindamycin and triamcinolone | Experimental | 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 Receives: Drug: Clindamycin Phosphate; Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without grade 2 or higher skin toxicity
device-related skin adverse events by investigator assessment.
Measured: up to 120 days
Secondary outcomes (1)
skin-related quality of life
using the PRO-CTCAE for rash, ulcer, and pruritus.
Measured: up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start9 Jul 2020
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a phase 2, multicenter, open-label study.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alina Markova, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469075
- Sponsor's protocol ID
- 19-342
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04469075
- Acronym / sponsor ID
- 19-342
- Conditions
- Glioblastoma, Recurrent Glioblastoma, Skin Toxicity
- Keywords
- Clindamycin, Triamcinolone, Skin-Related Side Effects, Recurrent, 19-342
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase 2, multicenter, open-label study.
| Arm | Type | Receives |
|---|---|---|
| topical clindamycin and triamcinolone | Experimental | Drug: Clindamycin Phosphate, Drug: Triamcinolone AcetonidePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clindamycin Phosphatephosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent) | Drug | topical clindamycin and triamcinolone |
| Triamcinolone Acetonidetriamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change | Drug | topical clindamycin and triamcinolone |
Primary outcome
Number of patients without grade 2 or higher skin toxicity
Time frame: up to 120 days
device-related skin adverse events by investigator assessment.
1 secondary outcome
skin-related quality of life
Time frame: up to 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Markova, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clindamycin Phosphate and Triamcinolone Acetonide in people with Glioblastoma and Recurrent Glioblastoma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients without grade 2 or higher skin toxicity (time frame: up to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.