Phase 2
N=2
Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01781026 ↗Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Apr 2015
Primary outcome: Primary: Activity of Vemurafenib in Untreated Brain Metastases
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vemurafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Activity of Vemurafenib in Untreated Brain Metastases |
— | — |
Summary
The purpose of this trial is to study the activity of vemurafenib in untreated melanoma brain metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that are not amenable to stereotactic radiosurgery based on size, number of lesions or location, to measure cerebrospinal fluid (CSF) levels of vemurafenib as an indicator of central nervous system penetrance and to measure levels of vemurafenib in normal brain tissue and brain metastases in those in whom surgical management is feasible.
Eligibility Criteria
Inclusion Criteria
- Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations.
- Untreated brain metastases
- At least one cerebral metastasis that is not amenable to stereotactic radiosurgery (SRS) or surgical resection based on size or location OR four or more lesions
- Patients may be symptomatic at the time of enrollment, but after any necessary local therapy and/or corticosteroids, the patient should be asymptomatic when vemurafenib is initiated.
- Age >18
- Adequate organ function
- ECOG performance status 450 ms at baseline or history of congenital long QT syndrome
- Uncontrolled medical illness, such as uncontrolled infection, congestive heart failure and MI within 2 months.
- Second active, untreated malignancy, which is likely to result in the patient's demise prior to death from uncontrolled melanoma CNS metastases. This will be determined on a case by case basis by the PIs.
- Unwillingness to undergo monitoring for a secondary malignancy including clinical dermatologic examinations and head and neck examinations and serial CT scans.
Data sourced from ClinicalTrials.gov (NCT01781026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.