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Clindamycin + Triamcinolone for Glioblastoma Skin Side Effects

Phase 2
Recruiting
Led By Mario Lacouture, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 days
Awards & highlights

Study Summary

This trial will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects for people being treated with Tumor Treating Fields for malignant glioma.

Who is the study for?
This trial is for adults over 18 with newly diagnosed or recurrent Glioblastoma (GBM) who are starting treatment with Tumor Treating Fields (TTFields). Participants must be able to apply topical treatments themselves or have someone to do it for them. They shouldn't be on high doses of dexamethasone, have scalp conditions like psoriasis, active infections requiring antibiotics, use other scalp treatments, or be allergic to the study lotions.Check my eligibility
What is being tested?
The study is testing if clindamycin and triamcinolone topical lotions can prevent skin issues caused by TTFields in GBM patients. It's seeing if these lotions applied where the TTFields device touches the skin can reduce side effects compared to not using them.See study design
What are the potential side effects?
Potential side effects from clindamycin and triamcinolone may include skin irritation, dryness, redness, itching at the application site. There could also be an increased risk of infection due to immune system suppression by triamcinolone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can apply medicine on my skin myself or have someone to help me.
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I will start TTF treatment within 7 days before joining this trial.
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I have been diagnosed with new or returning GBM and will start treatment with TTFields.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients without grade 2 or higher skin toxicity
Secondary outcome measures
skin-related quality of life

Trial Design

1Treatment groups
Experimental Treatment
Group I: topical clindamycin and triamcinoloneExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide
2018
Completed Phase 4
~3730
Clindamycin Phosphate
2019
Completed Phase 1
~550

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,562 Total Patients Enrolled
16 Trials studying Glioblastoma
1,227 Patients Enrolled for Glioblastoma
Mario Lacouture, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
2,049 Total Patients Enrolled
Alina Markova, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
789 Total Patients Enrolled

Media Library

Clindamycin Phosphate Clinical Trial Eligibility Overview. Trial Name: NCT04469075 — Phase 2
Glioblastoma Research Study Groups: topical clindamycin and triamcinolone
Glioblastoma Clinical Trial 2023: Clindamycin Phosphate Highlights & Side Effects. Trial Name: NCT04469075 — Phase 2
Clindamycin Phosphate 2023 Treatment Timeline for Medical Study. Trial Name: NCT04469075 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where is this clinical experiment being conducted?

"This medical study is currently open to patients from 9 different sites. These locations include the cities of Boston, Rochester and New york alongside 6 other metropolitan areas. To minimize travel needs during your participation in this trial, it's essential that you select a clinic close by."

Answered by AI

Are there any vacancies available in this research initiative?

"Affirmative. Per the details hosted on clinicaltrials.gov, this trial inaugurated on July 9th 2020 and is actively seeking participants as of November 7th 2022. 58 volunteers are needed from nine different medical centres to complete the study."

Answered by AI

What potential risks may be associated with using Clindamycin Phosphate?

"With existing data suggesting safety but no evidence of effectiveness, our team at Power has assigned Clindamycin Phosphate a score of 2 on its risk-benefit scale."

Answered by AI

What medical ailments is Clindamycin Phosphate typically administered to address?

"Clindamycin Phosphate is frequently prescribed for the treatment of bacterial endocarditis, and can also be utilized to help mitigate symptoms from anaerobic bacteria, ulcerative colitis and hand infections."

Answered by AI

What is the current enrollment of this trial?

"Affirmative. According to the clinicaltrials.gov database, this medical trial is currently accepting applicants and was initially posted on July 9th 2020 before being modified on November 7th 2022. To complete the study, 58 participants need to be recruited from 9 different sites."

Answered by AI

Can you enumerate any prior trials featuring Clindamycin Phosphate?

"Clindamycin Phosphate has been studied since 2005 under the direction of Hamid Ahmadieh, MD. With 292 clinical trials completed and currently 55 actively recruiting studies, it is evident that Boston, Massachusetts serves as a major hub for this research."

Answered by AI
~14 spots leftby Jul 2025