Clinical trial · Interventional
rRp450-Phase I Trial in Liver Metastases and Primary Liver Tumors
NCT01071941CI-TRIAL-00078038terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
| Primary Liver Cancers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| administration of rRp450 into the hepatic artery | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- The first subjects will receive a single infusion of rRp450. Subsequent subjects will receive rRp450 as four doses administered every 1-2 weeks.
- interventionNames
- Biological: administration of rRp450 into the hepatic artery
Primary outcomes (4)
- measure
- Evaluate the safety and tolerability of rRp450 administered into the hepatic artery as a single dose.
- timeFrame
- 3 years
- measure
- Evaluate the safety and tolerability of rRp450 administered into the hepatic artery as four doses administered every 1-2 weeks.
- timeFrame
- 3 years
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Prior exposure to HSV-1 as determined by blood test 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 acyclovir or inability to receive contract for CT and MRI scans * 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).
References
Publications (0)
Data not yet available
No reference posted for this study.