Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328887
Status:
WITHDRAWN
Last Update Posted:
2016-05-03
First Post:
2006-05-22
Brief Title:
Safety Study on the Transfer of the CD40 Ligand Gene AdcuCD40L to Patients With Esophageal Carcinoma
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase I Initial SafetyToxicity Study on the Transfer of Adenovirus With the CD40 Ligand Gene AdCUCD40L to Patients With Stage III or IV Esophageal Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding was obtained for this study No subject were receruited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This a pilot clinical study focused on enhancing the patients anti-tumor immune response in individuals with esophageal cancer by altering the genetic repertoire of the tumors to express CD40L an activator of dendritic cells This will be accomplished by endoscopic administration to the tumors of AdcuCD40L an adenovirus gene transfer vector expressing the coding sequence of the human CD40L cDNA This study is designed to assess the hypothesis that it is safe to administer the AdcuCD40L vector to individuals with esophageal cancer
Detailed Description:
Esophageal cancer is a deadly disease with only slow advances in therapy over several decades despite a rapid increase in incidence Esophageal cancer is estimated to be the seventh most common malignancy worldwide with incidence rates reaching epidemic proportions in select regions in Asia and Africa In the United States it is estimated that 12300 new cases were diagnosed in 2000 however the incidence of adenocarcinoma of the esophagus is currently rising faster than that of any other human malignant tumor in this country Despite advances in surgical technique chemotherapy radiotherapy and early detection only 12 of patients diagnosed with esophageal cancer will survive more than five years a cure rate more dismal than that seen with cancers of the breast prostate colon and even lung Survival following treatment for esophageal cancer is stage dependent This study is directed towards augmenting host anti-tumor immunity by using gene transfer to activate dendritic cells DC cells of our immune system that play a central role in initiating immune responses in tumors of patients with esophageal cancer Based on extensive pre-clinical data two proposed clinical trial protocols will evaluate the concept that transient modification of the genetic repertoire of esophageal tumors to express CD40 Ligand CD40L a potent activator of DC will induce the accumulation of activated DC within the tumor and the in vivo interaction of DC with the tumor cellstumor antigens will induce tumor-specific immunity To assess this concept an adenovirus Ad vector AdcuCD40L will be used to transfer and transiently express the human CD40L cDNA in esophageal carcinoma by direct injection into the tumor Phase I represents a dose escalation study to determine the maximum tolerated dose of the vector and will include 12 individuals with unresectable stage III or IV esophageal cancer Phase II is a randomized double-blinded assessment of biologic efficacy and will include 24 individuals with resectable stage I-III disease who will be undergoing potentially curative resection Together both protocols are designed to assess two hypotheses First that it is safe to administer the AdcuCD40L vector to individuals with esophageal cancer Second that intratumoral administration of the AdCUCD40L vector will induce both the accumulation in the tumor and in regional lymph nodes of activated DC and CD8 T cells and other inflammatory cells including T cells exhibiting tumor-specific responses as well as systemic antitumor immunity
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 |
|---|---|---|---|
| 5 R01 CA10198-02 | OTHER_GRANT | National Cancer Institute | None |