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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients without grade 2 or higher skin toxicity

Secondary study objectives

skin-related quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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