NINDS is seeking persons with severe pain from advanced cancer to participate in a research study. This study is investigating the safety and effectiveness of the experimental medication resiniferatoxin (RTX), which is being injected directly into the cerebrospinal fluid (CSF) of humans for the first time.
This study involves up to 8 visits to the NIH Clinical Center in Bethesda, MD. There will be one inpatient admission lasting 2-3 days to receive a single dose of the study drug, which is given under general anesthesia. Study evaluations include a history and physical examination, eye examination, sensory testing, blood draws, pregnancy test, magnetic resonance imaging (MRI), electrocardiogram (EKG), and completion of pain questionnaires. Telephone follow up will continue for 7 months after the treatment.
Volunteers must be 18 years of age or older, have cancer, and have severe pain below the chest that has not improved with standard treatment. They must also agree to live with a responsible adult and not seek any new cancer treatment for 15 days after receiving the study drug. Those who are pregnant or have impaired blood clotting, CSF shunts, implanted metal objects, or allergy to chili peppers or capsaicin are not eligible to participate.
This study will take place at the NIH Clinical Center. There is no cost for participation, for the study medication, or for any of the tests associated with the research study. Travel costs may be reimbursed.
For more information, contact Lisa Farinelli, RN, at 301-594-8118. Please refer to study number 09-D-0039.