Salt Lake City,
This is a Phase I dose escalation trial. The purpose of this study is to determine the
maximum tolerated dose of radiation received during stereotactic radiosurgery in patients
with brain metastases who have never received radiation to the brain before.
- Clinically confirmed brain metastases by CT or MRI criteria. If there is evidence of
extra-cranial metastatic disease, it is preferable that the lesions be pathologically
confirmed (see section 4.2.5 for excluded histologies) and reviewed by a University of
Utah or Huntsman Cancer Hospital pathologist if the initial review was done at an
- Prior brain surgery is allowed, although a lesion situated in the operative bed would
not be selected to receive an experimental dose of SRS treatment. SRS should be
delivered 4-6 weeks post-surgery if the patient had had a craniotomy for resection of
a lesion. Enrollment of a patient with the goal of performing SRS outside of the 4-6
post-craniotomy window is at the PI's discretion.
- Patients must have 1-5 brain metastases total.
- Maximum tumor diameter ≤ 40 mm by CT or MRI measurement at the time of
consultation/screening (for each metastatic lesion present in the brain).
- All metastatic lesions must be separated by a minimum of 3 cm as measured from the
peripheral edges of the lesions which are in closest proximity to one another. If
multiple lesions are present and are not all ≥ 3 cm away from each other, the patient
will be deemed ineligible.
- Prior systemic therapy is allowed, although appropriate washout is required for
patients who have been on BRAF inhibitors (at least 7 days).
- For subjects currently on active systemic cancer therapy, the treating medical
oncologist should be consulted to ensure proper washout (if appropriate) periods prior
- Patients must be at least 18 years of age.
- Karnofsky Performance Status (KPS) ≥ 60.
- Able to provide informed consent and have signed an approved consent form that
conforms to federal and institutional guidelines.
- Women of child-bearing potential must have a negative pregnancy test within 10 days of
study enrollment and must agree to use an acceptable method of birth control while
receiving radiation and for 3 months after radiation. Women of non-childbearing
potential may be included if they are either surgically sterile or have been
postmenopausal for >1 year.
- Men who are able to father a child must agree to use an acceptable method of birth
control while receiving radiation, and for 3 months after radiation.
- Prior whole/partial brain irradiation or stereotactic radiosurgery
- Brain lesions with a maximal diameter of > 40 mm in size on MRI imaging at the time of
consultation/screening for protocol eligibility.
- Lesion located in anatomic regions that are not amendable to SRS, including the brain
stem, optic apparatus, or eloquent cortex
- Radiographic or cytologic evidence of leptomeningeal disease
- Primary lesion with radiosensitive histology that includes the following: small cell
carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma
- Women of child-bearing potential who are pregnant or breast feeding
- Patients with multiple lesions, which by size criteria would be enrolled in a cohort
which is full at the time of enrollment and the 12 weeks DLT period has not been