- Age > 18 years old
- Diagnosis of BRAFV600 mutated Stage IV or unresectable Stage III melanoma
- Actively receiving treatment with vemurafenib as single agent and tolerating at least
720 mg bid for one cycle (28 days).
- In the opinion of the investigator, patients who are progressing in an area where
radiation may provide benefit from either:
- Symptom control
- Oligo-progression, defined as progression in up to 3 areas where focal treatment
would provide benefit.
- Patients with brain metastases will be allowed provided they meet all of the
- Small, < 1cm metastases which are untreated are allowed so long as in the
opinion of the investigator they do not require immediate treatment by radiation
- Asymptomatic, treated brain metastases which are stable for 4 weeks prior to
study entry are allowed
- If patients are requiring steroids for their brain metastases, they must be on a
stable dose for two weeks prior to study entry, and maintain that steroid dosing
during the radiation treatments
- Adequate bone marrow function as defined by: ANC > 1.0 k/uL, Platelets > 75 k/uL,
Hemoglobin > 8 g/dL
- Adequate hepatic function: Total bilirubin < 1.5 times the institutional upper limit
of normal, ALT/AST < 2.5 times the institutional upper limit of normal
- Adequate renal function as defined by serum creatinin < 1.5 times the upper limit of
- Negative serum pregnancy test at screening for women of child bearing potential
within 10 days of starting vemurafenib treatment . Women of non-childbearing
potential may be included if they are either surgically sterile or have been
postmenopausal for > 1 year
- Fertile men and women must agree to use an acceptable method of birth control during
treatment and for at least 2 months after discontinuation of vemurafenib.
- Able and willing to provide informed consent to an approved consent form that
conforms to federal and institutional guidelines.
- Screening QTc interval > 450 msec on EKG
- Known HIV positivity or AIDS-related illness, or active HBV, or active HCV.
- Any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, serious cardiac arrhythmia requiring
medication, uncontrolled hypertension, cerebrovascular accident or transient ischemic
attack, or symptomatic pulmonary embolism.
- Malabsorption disorder that would preclude adequate vemurafenib absorption.
- Other medical condition present that in the opinion of the investigator will hinder
the subjects ability to complete the study.