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

Status: Recruiting
Phase: Phase 1
Diagnosis: Liver Cancer
NCT ID: NCT01071941 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-042


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.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Kenneth Tanabe, MD, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - 18 years of age or more and able to understand and sign a written informed consent form - Histologically confirmed diagnosis of cancer with liver metastases, or histologically confirmed primary liver cancer (e.g. hepatocellular carcinoma, cholangiocarcinoma, or gallbladder carcinoma). Subjects may have extrahepatic spread of malignancy, except they may not have brain metastases. Subjects with a history of more than one invasive malignancy remain eligible for this study, but in these instances, a liver biopsy is required to document the histology of the liver tumor. An exception to this criterion is made for basal cell carcinoma. - Subjects must have primary or metastatic liver malignancies which are surgically unresectable, and exhausted all standard therapeutic options - Patients with hepatocellular carcinoma must have received sorafenib as one of the standard treatment options prior to being enrolled into the study - No liver surgery (including radiofrequency ablation), chemotherapy (including bevacizumab), immunotherapy, or liver radiotherapy within 4 weeks of enrollment. - ECOG performance status 0, 1 or 2 and life expectancy of greater than 12 weeks based on the investigator's clinical judgment. - Serum hematology and chemistry test results as outlined in the protocol. - Tumor volume occupies less than 50% of liver by volume as assessed by CT scan or MRI scan within 4 weeks of treatment - Negative pregnancy test (serum or urine) in premenopausal women Exclusion Criteria: - Clinical or pathological diagnosis of cirrhosis, hemachromatosis, or heptic fibrosis - Ascites or complete occlusion of main portal vein - Hepatitis C infection, chronic infection with hepatitis B, infection with HIV, or evidence of hepatic insufficiency - Inability to practice contraception with condoms as prescribed by the protocol - Active infection requiring treatment with systemic antibiotics or systemic anti-fungal agents - Being treated with immunosuppressive agents such as systemic corticosteroids or cyclosporine - Unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, or need for antiarrythmic medication for which inability to take an oral preparation of regular medication for 48 hours would represent an unacceptable risk. - Known existing uncontrolled coagulopathy, hemorrhagic disorder, or inability to discontinue coumadin or plavix for 5 days prior to each treatment (except for prophylaxis against portacath-associated thrombosis, which does not require cessation of therapy). - History of seizures - Allergy to IV contrast or allergy to acyclovir - Prior liver resection of greater than 2 anatomic segments as defined by Couinaud (subjects that have undergone prior liver wedge excisions or segmental resections are not excluded on this basis alone).
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