Clindamycin + Triamcinolone for Glioblastoma Skin Side Effects

Not currently recruiting at 9 trial locations

Overseen By Alina K Markova, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Topical therapies, Antibiotics, Dexamethasone

Disqualifiers: Scalp disorders, Infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two topical lotions, clindamycin (an antibiotic) and triamcinolone (a corticosteroid), can prevent skin problems caused by Tumor Treating Fields (TTFields) in people with malignant glioma, a type of brain cancer. Participants will use these lotions to reduce or avoid skin side effects from TTFields. Eligible participants are adults recently diagnosed with glioblastoma (a type of brain tumor) who are about to start TTFields treatment and can apply the lotions themselves or have assistance. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

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 there any evidence suggesting that clindamycin and triamcinolone are likely to be safe for humans?

Research has shown that using clindamycin and triamcinolone together is generally safe. Past studies found that the side effects of these treatments were similar to those of a placebo, a harmless treatment used for comparison. Notably, when used for skin issues, no moderate to severe skin problems were reported, indicating that the treatments are well-tolerated.

These medications are commonly used for various skin conditions, and their safety is well-known. Clindamycin, an antibiotic, fights bacteria, while triamcinolone, a steroid, reduces swelling. Both are applied to the skin and have been safely used by many people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using clindamycin phosphate and triamcinolone acetonide for glioblastoma skin side effects because these treatments offer a novel approach to managing the skin reactions caused by TTFields therapy. Unlike traditional systemic therapies for glioblastoma, which focus on the tumor itself, this combination is applied topically to specifically target and alleviate the skin irritation associated with the treatment. Clindamycin is an antibiotic that helps prevent infection, while triamcinolone is a steroid that reduces inflammation and itching. This localized treatment could provide relief more directly and with fewer systemic side effects compared to oral medications.

What evidence suggests that clindamycin and triamcinolone could be effective for preventing skin side effects of TTFields?

This trial will evaluate the combination of clindamycin and triamcinolone for managing skin side effects in patients undergoing Tumor Treating Fields (TTFields) therapy for glioblastoma. Studies have shown that clindamycin, an antibiotic that fights bacteria, and triamcinolone, a steroid that reduces swelling and itching, can help manage skin side effects. Research indicates that these two treatments work well together to soothe skin issues. In past studies, these lotions led to fewer skin problems and had similar safety results compared to other treatments. This combination has shown promise in managing skin reactions, offering a hopeful option for those undergoing TTFields therapy for glioblastoma. ^{1 2 3 5 6}

Who Is on the Research Team?

Alina K Markova, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Clindamycin Phosphate
• Triamcinolone Acetonide

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Clindamycin phosphate 1.2%/tretinoin 0.025% (Clin-RA) demonstrated significantly greater efficacy in reducing acne lesions compared to clindamycin, tretinoin, and vehicle in a pooled analysis of 4550 patients across three 12-week studies.

Clin-RA was found to be safe, with similar adverse event rates to the vehicle group, and it showed superior results in both adolescents and patients with mild to moderate acne, making it a strong candidate for first-line treatment of facial acne.

NCBI (Pubmed)

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. Dréno, B., Bettoli, V., Ochsendorf, F., et al.[2014]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04469075

NCT04469075 | Clindamycin and Triamcinolone in People ... This study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of TTFields. Official Title. The PROTECT ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04469075?term=AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(CLINTABS)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL))&rank=9

NCT04469075 | Clindamycin and Triamcinolone in People ... This study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of TTFields. Official Title. The PROTECT ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-05324

Clindamycin and Triamcinolone in People with ... This phase II trial studies how well clindamycin and triamcinolone work in preventing skin-related side effects of tumor treating fields (TTFields) in patients ...

4. withpower.com withpower.com/trial/phase-3-glioblastoma-6-2020-6337a

Clindamycin + Triamcinolone for Glioblastoma Skin Side ... Clin-RA was found to be safe, with similar adverse event rates to the vehicle group, and it showed superior results in both adolescents and patients with mild ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04469075/clindamycin-and-triamcinolone-in-people-with-glioblastoma-to-prevent-skin-related-side-effects-of-tumor-treating-fields

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9873416/

Expert guidance on prophylaxis and treatment of ... Preliminary data extrapolated from glioblastoma experience suggests that the two treatments can be utilized with no moderate-severe skin toxicities reported (29 ...