Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00072098|
Recruitment Status : Terminated (limited funding)
First Posted : November 6, 2003
Last Update Posted : January 11, 2017
RATIONALE: Inserting the interleukin-12 gene into a person's 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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer||Biological: adenovirus vector Biological: interleukin-12 gene||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Experimental Group
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene
Biological: adenovirus vector
Biological: interleukin-12 gene
- safety measure [ Time Frame: up to day 57 ]adverse event reporting
- toxicity grading [ Time Frame: up to day 57 ]toxicity will assessed from grades 0 to 4 as per common toxicity criteria
- tumor response compared at four weeks to baseline [ Time Frame: baseline and four weeks ]tumor masses enumerated and measured pre-treatment and 4 weeks after treatment and changes in the tumor calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072098
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Max W. Sung, MD||Icahn School of Medicine at Mount Sinai|