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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical clindamycin and triamcinolone | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin Phosphate | Drug | phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients without grade 2 or higher skin toxicity | device-related skin adverse events by investigator assessment. | up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| skin-related quality of life | using the PRO-CTCAE for rash, ulcer, and pruritus. | up to 120 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alina Markova, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Evanston | Illinois | 60208 | United States | ||
| Tufts Medical Center |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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This is a phase 2, multicenter, open-label study.
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| Triamcinolone Acetonide | Drug | triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change |
|
| Boston |
| Massachusetts |
| 02111 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack Meridian Health | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities) | Hauppauge | New York | 11788 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C007084 | clindamycin phosphate |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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