Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012155
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-03-03
Brief Title:
Gene Therapy in Treating Patients With Colon Cancer That Has Spread to the Liver
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Open-Label Dose-Escalating Study Of The Safety Tolerability And Anti-Tumor Activity Of A Single Intrahepatic Arterial Injection Of Genetically Engineered Herpes Simplex Virus NV1020 In Subjects With Adenocarcinoma Of The Colon With Metastasis To The Liver
Status:
COMPLETED
Status Verified Date:
2002-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Gene therapy may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the safety of NV1020 in patients who have colon cancer that has spread to the liver and has not responded to previous chemotherapy
PURPOSE Phase I trial to study the safety of NV1020 in patients who have colon cancer that has spread to the liver and has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES
Determine the safety and maximum tolerated dose of a single intrahepatic NV1020 injection in patients with hepatic metastases from colon cancer that has failed first-line chemotherapy
Determine the tolerability of this drug in these patients
Determine preliminarily the anti-tumor activity of this drug in these patients
Assess the immunogenicity of NV1020 in these patients
OUTLINE This is a dose escalation study
Patients receive a single intrahepatic arterial injection of NV1020 over 10 minutes with the aid of hepatic arteriography
Cohorts of 3 patients receive escalating doses of NV1020 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed at 1 2 and 3 months post injection Patients may participate in a separate long term up to 1 year follow-up study for continued assessment and monitoring
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
Determine the safety and maximum tolerated dose of a single intrahepatic NV1020 injection in patients with hepatic metastases from colon cancer that has failed first-line chemotherapy
Determine the tolerability of this drug in these patients
Determine preliminarily the anti-tumor activity of this drug in these patients
Assess the immunogenicity of NV1020 in these patients
OUTLINE This is a dose escalation study
Patients receive a single intrahepatic arterial injection of NV1020 over 10 minutes with the aid of hepatic arteriography
Cohorts of 3 patients receive escalating doses of NV1020 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed at 1 2 and 3 months post injection Patients may participate in a separate long term up to 1 year follow-up study for continued assessment and monitoring
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068488 | REGISTRY | None | None |
| MGENE-NR1-001 | None | None | None |
| NCI-G01-1920 | Registry Identifier | PDQ Physician Data Query | None |