Clinical Trial: rRp450-Phase I Trial in Liver Metastases and Primary Liver Tumors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: rRp450-Phase I Trial in Liver Metastases and Primary Liver Tumors

Brief Summary: The purpose of this research study is to determine the safety of rRp450 and the highest dose of this agent that can be given to people safely. We are also looking to see how well the body tolerates the study agent, how the agent is absorbed by the liver cancers, how quickly the agent is eliminated from the body, and what kind of anti-cancer 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.

Detailed Summary:

  • 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 s
    Sponsor: Kenneth K. Tanabe, MD

    Current Primary Outcome:

    • 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 ]


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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 ]


    Original Secondary Outcome:

    • Assess the relationship between systemic rRp450 viremia, HSV-1 neutralizing titers and 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 ]


    Information By: Massachusetts General Hospital

    Dates:
    Date Received: January 13, 2010
    Date Started: October 2010
    Date Completion: May 2017
    Last Updated: September 13, 2016
    Last Verified: September 2016