Using clindamycin and triamcinolone to prevent skin side effects from glioblastoma treatment
The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields
This study is testing if using clindamycin and triamcinolone can help prevent skin problems for people with glioblastoma who are receiving Tumor Treating Fields treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 8 sites (Evanston, Illinois and 7 other locations) |
| Trial ID | NCT04469075 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of topical clindamycin and triamcinolone in preventing skin-related side effects caused by Tumor Treating Fields (TTFields) in patients with newly diagnosed or recurrent glioblastoma. Participants will apply these topical agents while undergoing TTFields treatment, which is known to potentially cause skin toxicity. The study aims to determine if these interventions can improve the tolerability of TTFields therapy. Eligible patients must be able to self-administer the treatments or have someone assist them.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed or recurrent glioblastoma who are about to start TTFields treatment.
Not a fit: Patients with known allergies to the study agents or preexisting scalp disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce skin-related side effects for glioblastoma patients undergoing TTFields therapy, improving their overall treatment experience.
How similar studies have performed: While this specific approach is novel, similar studies have explored topical treatments for skin toxicity in cancer therapies, showing varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Diagnosis of newly diagnosed or recurrent GBM with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution * Able to self-administer topical interventions or has available another person who can apply the topical agents * Treatment with TTF should be initiated within 7 days of planned initiation on this trial. Exclusion Criteria: * Known history of allergy to any ingredient of the study agents * 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. * Use of concurrent topical therapy to the scalp for another dermatologic condition * Active, uncontrolled infection requiring systemic or oral antibiotic therapy within 14 days of enrollment * Use of greater than 4 mg dexamethasone a day within 14 days of enrollment * Malignant glioma * Pregnant Women
Where this trial is running
Evanston, Illinois and 7 other locations
- Northwestern University — Evanston, Illinois, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Active_not_recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Active_not_recruiting)
- Hackensack Meridian Health — Hackensack, New Jersey, United States (Active_not_recruiting)
- Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities) — Hauppauge, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Active_not_recruiting)
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Alina Markova, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Alina Markova, MD
- Email: markovaa@mskcc.org
- Phone: 646-608-2342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.