rRp450-Phase I Trial in Liver Metastases and Primary Liver Tumors
- Since we are looking for the highest dose of the study agent 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
- 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
- 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, swab
samples of saliva, blood test to see if the body has 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety and tolerability of rRp450 administered into the hepatic artery as a single dose.
Kenneth K. Tanabe, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|