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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

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 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 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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,752 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

Recent research and studies

clinicaltrials.govStudy

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

2020. "Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04469075.

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