rRp450-Liver Metastases and Primary Liver Tumors

2014-08-27 03:15:48 | BioPortfolio


The purpose of this research study is to determine the safety of rRp450 and the highest dose of this drug that can be given to people safely. We are also looking to see how well the body tolerates the study drug, how the drug is absorbed by the body, how it is processed, and what kind of anti-tumor 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.


- Since we are looking for the highest dose of the study drug 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.

- 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, samples of saliva and swabs of the skin of the penis or vaginal secretions, blood test to see if the body as 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Liver Metastases




Massachusetts General Hospital
United States


Not yet recruiting


Massachusetts General Hospital

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:48-0400

Clinical Trials [1884 Associated Clinical Trials listed on BioPortfolio]

Comparison of Triphasic CT, PET and MR Tumour With Pathological Findings in Colorectal Cancer Liver Metastases

The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver metastases to pathologic appearance ot better understand the accuracy of imaging to determine t...

The Role of Fluorothymidine Positron Emission Tomography (FLT-PET) in Proliferation of Colorectal Liver Metastases

The aim of the study is to obtain information on FLT used in a PET-scan as a marker for the proliferation of colorectal liver metastases, so that the risk of recurrence can be identified i...

3D Dynamic Contrast-Enhanced Ultrasound Imaging in Predicting Treatment Response in Patients With Liver Metastases From Colon Cancer

Patients are invited to participate in a research study of liver perfusion (how blood flows to the liver over time). Researchers hope to learn whether perfusion characteristics of liver me...

Quality of Life and Liver Metastases

An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status o...

Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases

Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.

PubMed Articles [4848 Associated PubMed Articles listed on BioPortfolio]

Prospective Evaluation of Intrahepatic Microscopic Occult Tumor Foci in Patients with Numerous Colorectal Liver Metastases.

Patients with numerous colorectal liver metastases (CLM) have high risk of early recurrence after liver resection (LR). The presence of intrahepatic occult microscopic metastases missed by imaging has...

Levels of choline-containing compounds in normal liver and liver metastases of colorectal cancer as recorded by H MRS.

A relatively high signal for choline-containing compounds (total choline, tCho) is commonly found in H MR spectra of malignant tumors, but it is unclear if this also occurs in tumors in the liver. We...

Contrastive analysis of ultrasonographic features of synchronous and heterochronic liver metastasis in patients with stromal tumor.

To investigate the ultrasonographic features of synchronous and heterochronic liver metastasis in patients with stromal tumors, and to elucidate the value of ultrasonic examination in follow-up surger...

Host MICA Polymorphism as a Potential Predictive Marker in Response to Chemotherapy for Colorectal Liver Metastases.

Understanding the genetic background of a tumor is important to better stratify patient prognosis and select optimal treatment. For colorectal liver metastases (CLM), however, clinically available bio...

Routine MRI With DWI Sequences to Detect Liver Metastases in Patients With Potentially Resectable Pancreatic Ductal Carcinoma and Normal Liver CT: A Prospective Multicenter Study.

The purpose of this study was to evaluate the performance of systematic MRI with DWI for the detection of liver metastases (LM) in patients with potentially resectable pancreatic ductal carcinoma and ...

Medical and Biotech [MESH] Definitions

Irradiation of one half or both halves of the body in the treatment of disseminated cancer or widespread metastases. It is used to treat diffuse metastases in one session as opposed to multiple fields over an extended period. The more frequent treatment modalities are upper hemibody irradiation (UHBI) or lower hemibody irradiation (LHBI). Less common is mid-body irradiation (MBI). In the treatment of both halves of the body sequentially, hemibody irradiation permits radiotherapy of the whole body with larger doses of radiation than could be accomplished with WHOLE-BODY IRRADIATION. It is sometimes called "systemic" hemibody irradiation with reference to its use in widespread cancer or metastases. (P. Rubin et al. Cancer, Vol 55, p2210, 1985)

An antineoplastic antimetabolite that is metabolized to fluorouracil when administered by rapid injection; when administered by slow, continuous, intra-arterial infusion, it is converted to floxuridine monophosphate. It has been used to treat hepatic metastases of gastrointestinal adenocarcinomas and for palliation in malignant neoplasms of the liver and gastrointestinal tract.

Sudden liver failure in the presence of underlying compensated chronic LIVER DISEASE (e.g., LIVER CIRRHOSIS; HEPATITIS; and liver injury and failure) due to a precipitating acute hepatic insult.

Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed.

Experimentally induced chronic injuries to the parenchymal cells in the liver to achieve a model for LIVER CIRRHOSIS.

More From BioPortfolio on "rRp450-Liver Metastases and Primary Liver Tumors"

Quick Search


Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Gene Therapy
Gene therapy is the use of DNA as a pharmaceutical agent to treat disease. It derives its name from the idea that DNA can be used to supplement or alter genes within an individual's cells as a therapy to treat disease. The most common form of gene th...

Searches Linking to this Trial