Clindamycin + Triamcinolone for Glioblastoma Skin Side Effects

Recruiting at 8 trial locations

Overseen by Alina K Markova, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Topical therapies, Antibiotics, Dexamethasone

Disqualifiers: Scalp disorders, Infection, Pregnancy, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other topical treatments on your scalp or take more than 4 mg of dexamethasone daily within 14 days of joining the trial.

Is Clindamycin + Triamcinolone generally safe for humans?

Triamcinolone acetonide, a component of the treatment, is commonly used for its anti-inflammatory properties and is generally considered safe when used as directed. However, it can have side effects, such as skin irritation or changes, and its long-term effects are still being studied. Always consult with a healthcare provider for personalized advice. ^{1 2 3 4 5}

How does the drug Clindamycin + Triamcinolone differ from other treatments for glioblastoma skin side effects?

Clindamycin is an antibiotic often used for acne, and Triamcinolone is a steroid that reduces inflammation. This combination may offer a unique approach by addressing both infection and inflammation, which could be beneficial for managing skin side effects in glioblastoma patients, although this specific use is not well-documented in existing research. ^{6 7 8 9 10}

Research Team

Alina K Markova, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I can apply medicine on my skin myself or have someone to help me.

I will start TTF treatment within 7 days before joining this trial.

I have been diagnosed with new or returning GBM and will start treatment with TTFields.

Exclusion Criteria

I am using a topical treatment on my scalp for another skin condition.

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.

I haven't needed antibiotics for an infection in the last 14 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tumor Treating Fields (TTFields) therapy along with topical clindamycin and triamcinolone to prevent skin-related side effects

16 weeks

Follow-up

Participants are monitored for skin-related quality of life and adverse events

4 weeks

Treatment Details

Interventions

• Clindamycin Phosphate (Anti-bacterial)
• Triamcinolone Acetonide (Corticosteroid)

Trial Overview 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.

Participant Groups

Group I: topical clindamycin and triamcinolone Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Triamcinolone acetonide, at clinically relevant doses (200 microg/mL), was found to be toxic to retinal pigment epithelial (ARPE-19) and retinal neurosensory (R28) cells in vitro, reducing cell viability significantly after 24 hours of exposure.

The study indicated that while the vehicle used to suspend triamcinolone acetonide was nontoxic on its own, it may enhance the cytotoxic effects of the steroid, suggesting a need for caution in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity of triamcinolone acetonide on retinal neurosensory and pigment epithelial cells. Narayanan, R., Mungcal, JK., Kenney, MC., et al.[2013]

In an open trial involving 24 patients with persistent oral vesiculoerosive diseases, clobetasol propionate demonstrated significant efficacy, with 15 patients achieving complete remission and 7 showing excellent responses after using the medication 2-3 times daily.

The treatment was well-tolerated, with only minor and reversible side effects reported, making clobetasol propionate a promising alternative to less potent topical and systemic therapies for these challenging oral conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open preliminary clinical trial of clobetasol propionate ointment in adhesive paste for treatment of chronic oral vesiculoerosive diseases. Lozada-Nur, F., Huang, MZ., Zhou, GA.[2019]

A systematic review of six studies involving 54 patients indicated that topical steroids, including KENACOMB, can lead to rapid healing in burn wounds, with 86.6%-100% of wounds achieving complete reepithelialization after treatment.

Despite the observed efficacy, the review also highlighted potential adverse effects such as skin thinning and local infections, emphasizing the need for more rigorous research to establish the safety and effectiveness of topical steroids in burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical steroids in burn patients: A systematic review of the literature and a descriptive analysis of topical KENACOMB use at a major tertiary burn centre. Duff, MF., Lisec, C.[2022]

Topical clobetasol propionate 0.05% cream under occlusion with silicone dressing is as effective as intra-lesional triamcinolone for treating keloids, based on a study of 34 scars from 17 patients over 12 weeks.

The topical treatment has significantly fewer adverse effects, making it a safer alternative, especially for patients who may be sensitive to pain or prefer non-invasive options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Single-Blind Trial of Clobetasol Propionate 0.05% Cream Under Silicone Dressing Occlusion Versus Intra-Lesional Triamcinolone for Treatment of Keloid. Nor, NM., Ismail, R., Jamil, A., et al.[2018]

Intramuscular triamcinolone acetonide (Kenalog®) has a unique ability to provide long-lasting anti-inflammatory effects, making it distinct from other corticosteroids, which may be due to its low solubility in blood and slow absorption rate.

The efficacy of triamcinolone acetonide at low doses for treating dermatologic diseases suggests that its mechanism of action involves complex binding properties and metabolic pathways that are not yet fully understood, indicating potential for further research in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enigma of Intramuscular Triamcinolone Acetonide (Kenalog®) Efficacy. Shahinfar, S., Maibach, H.[2023]

In a 12-week study involving a comparison of a 5% benzoyl peroxide gel and a 1% clindamycin phosphate solution for treating acne vulgaris, benzoyl peroxide was found to be significantly more effective in reducing total acne lesions.

While both treatments reduced lesions, benzoyl peroxide caused more skin peeling and drying compared to clindamycin, which had a milder effect on the skin surface.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of benzoyl peroxide and clindamycin phosphate for treating acne vulgaris. Swinyer, LJ., Baker, MD., Swinyer, TA., et al.[2019]

A 22-year-old woman with systemic lupus erythematosus experienced severe allergic reactions, including pruritus, shortness of breath, and fever, shortly after taking sulindac, indicating a potential hypersensitivity to the medication.

Despite the adverse reaction, the patient's symptoms resolved within 24 hours, and the mechanism of the reaction does not appear to be related to prostaglandin synthesis inhibition, as she tolerated aspirin without issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sulindac-induced aseptic meningitis. Ballas, ZK., Donta, ST.[2013]

In a 12-week study, Clindagel, a once-daily gel formulation of clindamycin phosphate 1%, was found to be safe and effective for treating acne vulgaris, showing equivalent efficacy to Cleocin T, which is used twice daily.

Clindagel demonstrated a better tolerability profile compared to Cleocin T, making it a viable alternative for patients seeking acne treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clindamycin phosphate 1% gel in acne vulgaris. Rizer, RL., Sklar, JL., Whiting, D., et al.[2019]

A study involving 246 patients with mild to moderate acne showed that a 1% clindamycin/zinc gel applied once or twice daily is equally effective as a 1% clindamycin lotion applied twice daily over 16 weeks.

All treatment regimens resulted in minimal side effects, primarily mild irritant dermatitis, and showed a low emergence of resistant bacteria, suggesting that the clindamycin/zinc gel could improve patient compliance with once-daily application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observer-blind parallel-group, randomized, multicentre clinical and microbiological study of a topical clindamycin/zinc gel and a topical clindamycin lotion in patients with mild/moderate acne. Cunliffe, WJ., Fernandez, C., Bojar, R., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Toxicity of triamcinolone acetonide on retinal neurosensory and pigment epithelial cells. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Open preliminary clinical trial of clobetasol propionate ointment in adhesive paste for treatment of chronic oral vesiculoerosive diseases. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Topical steroids in burn patients: A systematic review of the literature and a descriptive analysis of topical KENACOMB use at a major tertiary burn centre. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

A Randomized, Single-Blind Trial of Clobetasol Propionate 0.05% Cream Under Silicone Dressing Occlusion Versus Intra-Lesional Triamcinolone for Treatment of Keloid. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Enigma of Intramuscular Triamcinolone Acetonide (Kenalog®) Efficacy. [2023]

6. France pubmed.ncbi.nlm.nih.gov

Efficacy and safety of clindamycin phosphate 1.2%/tretinoin 0.025% formulation for the treatment of acne vulgaris: pooled analysis of data from three randomised, double-blind, parallel-group, phase III studies. [2014]

7. England pubmed.ncbi.nlm.nih.gov

A comparative study of benzoyl peroxide and clindamycin phosphate for treating acne vulgaris. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Sulindac-induced aseptic meningitis. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Clindamycin phosphate 1% gel in acne vulgaris. [2019]

10. England pubmed.ncbi.nlm.nih.gov

An observer-blind parallel-group, randomized, multicentre clinical and microbiological study of a topical clindamycin/zinc gel and a topical clindamycin lotion in patients with mild/moderate acne. [2019]