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Liver Metastases and Primary Liver Tumors - Healing Genes
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Liver Metastases and Primary Liver Tumors

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

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


Phase 1

DESCRIPTION:

Massachusetts General Hospital doctors seek participants in a clinical investigation of a new treatment for liver tumors, including cancers metastasized to the liver. The investigatory drug, rRp450, is a genetically engineered oncolytic (cancer-killing) herpes simplex type 1 virus that targets tumor cells, killing some as it copies more viral particles to continue to target only cancer cells. It is believed that, when those tumor cells die, the immune system is prompted to respond and kill more tumor cells.

The study will require infusion of rRp450 into the hepatic artery either as a single infusion, or as four infusions administered every one to two weeks. Follow up may require lab assessments, imaging scans, and biopsies for up to 3 years.


PATIENT MUST:

  • Be 18 years of age or older
  • Have lab-confirmed diagnosis of cancer with liver metastases, or histologically confirmed primary liver cancer
  • Not be pregnant or breastfeeding.

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Administration of rRp450 into the hepatic artery either as a single infusion, or as four infusions administered every one to two weeks.
  3. During the injection of rRp450: vital signs, review of any side effects, research blood samples taken from arm vein and liver vein
  4. 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).
  5. Liver and tumor biopsies will be performed about 6 days after the rRp450 injection.
  6. 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.

LOCATIONS AND CONTACTS:
The study site is at Massachusetts General Hospital in Boston, MA. Map.
Contact: Kenneth K. Tanabe, MD  |  617-724-3868

SPONSOR INFORMATION:
Kenneth K. Tanabe, MD
National Cancer Institute (NCI)

Or go online:
https://clinicaltrials.gov/ct2/show/NCT01071941

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