Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT01721603
- Phase
- PHASE2
- Status
- Terminated
Conditions
- BRAFV600E Melanoma Patients
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dabrafenib — DRUG150 mg capsule by mouth twice daily
- Gamma Knife Radiosurgery — PROCEDUREThis will be delivered using Gamma Knife technology. Patients will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases.
- Trametinib — DRUG2 mg by mouth once daily from beginning at Cycle 3 Day 1, until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.
Study Details
The purpose of this study is to test the safety and find out what effects, good and/or bad, dabrafenib (a BRAF inhibitor) alone or dabrafenib when given in combination with gamma knife radiosurgery has on participants with a certain type of skin cancer (BRAFV600E melanoma) and brain metastases (tumors that have spread to the brain).
Key Dates
- Start date
- Apr 30, 2013
- Status verified
- Dec 2017
- Primary completion
- Jan 31, 2016
- Completion
- Jan 31, 2016
Study Design
- Enrollment
- 2 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dabrafenib + Trametinib + gamma knife radiosurgery
Primary Outcome Measure
Patients Reaching 6 Month Distant Brain Metastasis-free Survival (DBMFS) [ Time Frame: Up to 6 months after surgery ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of San Francisco, California | San Francisco | California | 94115 | - |
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