Radiation Use During Vemurafenib Treatment

This is an interventional treatment trial for BRAFV600 Mutation Read More

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.

Exclusion Criteria:

• 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.