rRp450-Phase I Trial in Liver Metastases and Primary Liver Tumors
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|ClinicalTrials.gov Identifier: NCT01071941|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2010
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Metastases Primary Liver Cancers||Biological: administration of rRp450 into the hepatic artery||Phase 1|
- 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 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. As of July, 2013, because the first phase of the study has been completed, all participants from here forward will receive 4 weekly injections of rRp450
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||rRp450-Phase I Trial in Liver Metastases and Primary Liver Tumors|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Group 1
The first subjects will receive a single infusion of rRp450. Subsequent subjects will receive rRp450 as four doses administered every 1-2 weeks.
Biological: administration of rRp450 into the hepatic artery
Administration of rRp450 into the hepatic artery either as a single infusion, or as four infusions administered every one to two weeks.
Other Name: rRp450
- Evaluate the safety and tolerability of rRp450 administered into the hepatic artery as a single dose. [ Time Frame: 3 years ]
- Evaluate the safety and tolerability of rRp450 administered into the hepatic artery as four doses administered every 1-2 weeks. [ Time Frame: 3 years ]
- Determine the dose-limiting toxicities and maximum dose of rRp450 that can be safely administered into the hepatic artery when administered weekly for four doses. [ Time Frame: 3 years ]
- Characterize rRp450 pharmacokinetics and viral shedding. [ Time Frame: 3 years ]
- Assess the relationship between systemic rRp450 levels and clinical toxicity. [ Time Frame: 3 years ]
- Evaluate tumor biopsies for rRp450 replication, tumor response and immune cell infiltrates. [ Time Frame: 3 years ]
- Correlate radiographic and pathologic assessments of tumor response. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071941
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Kenneth K. Tanabe, MD||Massachusetts General Hospital|