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A clinical research study for melanoma patients with newly diagnosed metastases to the brain or spine will test the combination of a drug, called ipilimumab (Yervoy), which targets the immune system, and stereotactic radiosurgery (CyberKnife), a precise type of radiation therapy. The research study will test the safety of the combination, which is given over the course of two months.
Who Can Join?
Eligible melanoma patients may include those with:
- Stage IV melanoma
- Newly-diagnosed melanoma that has spread (metastasized) to the brain or spine (not both)
What is Involved in the Clinical Trial?
As part of the experimental treatment, patients will receive an intravenous dose of ipilimumab, followed, a week later, by stereotactic radiosurgery, and three more doses of ipilimumab. The treatments are given over the course of approximately two months. Patients will be monitored with periodic imaging scans and blood tests. All treatments and tests are conducted at the Johns Hopkins East Baltimore Medical campus.
Ipilimumab was approved by the U.S. Food and Drug Administration in 2011 for use in melanoma patients. Studies showed that patients receiving the drug survived four months longer than patients receiving standard therapy. Other reports have shown that some melanoma patients with brain and spinal metastases have also responded to ipilimumab.
Stereotactic radiosurgery was approved by the U.S. Food and Drug Administration in 1995 for the treatment of any cancer that has metastasized to the brain and spine. Stereotactic radiosurgery delivers high doses of precisely-targeted radiation in one or two treatments, compared with less targeted external beam radiation that requires more than one or two treatments.
Research shows that radiation therapy may prime tumors to respond to subsequent immunotherapy, such as ipilimumab. This clinical trial will determine whether it is safe to give patients a combination of stereotactic radiosurgery and ipilimumab.
For more information or to see if you qualify, call Susan Zhen at 410-502-4081 or email Szhen1@jhmi.edu.