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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
Diagnosis of newly diagnosed or recurrent GBM with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
Age ≥18 years
Must not have
Use of concurrent topical therapy to the scalp for another dermatologic condition
Malignant glioma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 days
Awards & highlights

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am using a topical treatment on my scalp for another skin condition.
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I have been diagnosed with a malignant brain tumor.
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I have not taken more than 4 mg of dexamethasone daily in the last 2 weeks.

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
1,944 Previous Clinical Trials
589,693 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
~11 spots leftby Jul 2025
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