Radiation Use During Vemurafenib Treatment

Inclusion Criteria

• •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 following criteria:
• •* 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 or surgery
• •* 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 normal.
• •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.