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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Glioblastoma; Recurrent Glioblastoma; Skin Toxicity

Treatments: Drug: Clindamycin Phosphate; Drug: Triamcinolone Acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT04469075

19-342

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

topical clindamycin and triamcinolone

Experimental group

Description:

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:

Drug: Triamcinolone Acetonide

Drug: Clindamycin Phosphate