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The purpose of this research study is to determine the safety of rRp450 and the highest dose of this drug that can be given to people safely. We are also looking to see how well the body tolerates the study drug, how the drug is absorbed by the body, how it is processed, and what kind of anti-tumor effect it may have. rRp450 is a type of gene therapy and a form of the Herpes simplex virus 1 (or HSV). HSV is a virus that usually causes cold sores of the mouth. In extremely rare circumstances, this virus can cause severe infections, such as an infection of the brain. rRp450 was developed from an HSV and specially altered to target and kill cancer cells.
- Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have liver tumors, not everyone who participates in this research study will receive the same dose of the study drug. The dose the participant receives will depend on the number of participants who have been enrolled in the study before and how well they tolerated their doses.
- Depending upon when the participant enrolls in this study, they will either receive a single injection of rRp450, or up to 4 weekly injections of rRp450. Participants in both groups will be monitored after the rRp450 injection in the hospital and in the clinic.
- For the rRp450 injection, we will insert a small tube into the artery that supplies blood to the liver. rRp450 will be injected into this tube so it goes directly to the liver. Another tube is inserted into the blood vessel that drains blood from the liver. We will use this tube to take blood samples to monitor how the body absorbs and breaks down rRp450.
- After the rRp450 injection, participants will be monitored closely for any side effects. Vital signs will be closely monitored before, during and after rRp450 injection. After the rRp450 injection, the tubes are removed.
- The following tests and procedures are done before the rRp450 injection: determination of overall health condition, performance status evaluation, review of current medications and any side effects, physical exam and vital signs.
- The following tests and procedures will be done during the injection of rRp450: vital signs, review of any side effects, research blood samples taken from a vein in your arm, and research blood samples taken from your liver vein.
- The following tests and procedures will be done after rRp450 injection: 1 Hour after; blood tests: 6 and 12 hours after; blood tests, vital signs, routine blood tests, samples of saliva and swabs of the skin of the penis or vaginal secretions (hour 12 only): 24 hours after, Between days 4 to 7 and Between days 10 to 14; review of current medications and side effects, physical exam, vital signs, routine blood tests, samples of saliva and swabs of the skin of the penis or vaginal secretions, blood test to see if the body as produced antibodies against HSV-1 (only on day 4 to 7 and only for participants enrolled in the single injection group).
- Liver and tumor biopsies will be performed about 6 days after the rRp450 injection.
- Participants will be asked to return to the clinic 2 weeks, 4 weeks, and every 3 months thereafter after their last injection of study medication.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Massachusetts General Hospital
Not yet recruiting
Massachusetts General Hospital
Published on BioPortfolio: 2014-08-27T03:15:48-0400
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