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

Phase 2

Recruiting

• Conditions: Skin Toxicity; Glioblastoma; Recurrent Glioblastoma
• Interventions: Drug: Clindamycin Phosphate; Drug: Triamcinolone Acetonide

• Registration Number: NCT04469075
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-09
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
topical clindamycin and triamcinolone	Triamcinolone Acetonide	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
topical clindamycin and triamcinolone	Clindamycin Phosphate	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

Primary Outcome Measures

Name	Time	Method
Number of patients without grade 2 or higher skin toxicity	up to 120 days	device-related skin adverse events by investigator assessment.

Secondary Outcome Measures

Name	Time	Method
skin-related quality of life	up to 120 days	using the PRO-CTCAE for rash, ulcer, and pruritus.

Trial Locations

Locations (8)

Northwestern University; 🇺🇸 Evanston, Illinois, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Hackensack Meridian Health; 🇺🇸 Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities); 🇺🇸 Hauppauge, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States