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Sponsored by: |
MediGene |
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Information provided by: | MediGene |
ClinicalTrials.gov Identifier: | NCT00149396 |
This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.
Stage 2 is to evaluate the dose found in Stage 1 to be "optimally tolerated". Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy.
Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Liver Neoplasms |
Drug: NV1020 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Open-Label Study (With a Sequential Dose Escalation Stage Followed by an Expansion of a Selected Dose Cohort), to Evaluate the Safety and Anti-Tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-Line Chemotherapy, in Patients With Colorectal Adenocarcinoma Metastatic to the Liver |
Estimated Enrollment: | 27 |
Study Start Date: | July 2004 |
Study Completion Date: | December 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Significant active/unstable non-malignant disease or laboratory test (hematology and chemistry) results that meet any of the following:
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92093 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Pennsylvania | |
University of Pittsburgh Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
University of Vanderbilt | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75201 |
Study Director: | Hoda Tawfik, PhD | MediGene |
Responsible Party: | MediGene ( Alice Chen ) |
Study ID Numbers: | CT1030 |
Study First Received: | September 6, 2005 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00149396 |
Health Authority: | United States: Food and Drug Administration |
Colorectal cancer metastases to liver Colorectal Cancer Colorectal Carcinoma Colorectal Tumors Colorectal Neoplasms Rectum Cancer Rectum tumors Rectum carcinoma Colon cancer Colon tumors |
Colon carcinoma Rectum Neoplasms Colon Neoplasms Liver Neoplasms Hepatic Neoplasms Liver Tumors Liver cancer Hepatic Cancer Hepatic tumors metastatic to the liver |
Herpes Simplex Liver Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Liver neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Rectal neoplasm |
Carcinoma Liver Neoplasms Virus Diseases Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colonic Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |