Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072098
Status:
TERMINATED
Last Update Posted:
2017-01-11
First Post:
2003-11-04
Brief Title:
Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
Sponsor:
Max Sung
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
limited funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Inserting the interleukin-12 gene into a persons cancer cells may make the body build an immune response to kill tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer
Detailed Description:
OBJECTIVES
Determine the toxicity and maximum tolerated dose of intratumoral adenoviral vector-delivered interleukin-12 gene in patients with liver metastases secondary to colorectal cancer
Determine the tumor response in patients treated with this regimen
Determine the immune response in patients treated with this regimen
Determine the toxicity and maximum tolerated dose of intratumoral adenoviral vector-delivered interleukin-12 gene in patients with liver metastases secondary to colorectal cancer
Determine the tumor response in patients treated with this regimen
Determine the immune response in patients treated with this regimen
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 |
|---|---|---|---|
| NIH 9911-359 | None | None | None |
| MTS-GCO-975642 | None | None | None |
| MTS-GCO-971592 | None | None | None |
| CDR0000335463 | None | None | None |