Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358397
Status:
TERMINATED
Last Update Posted:
2016-10-14
First Post:
2006-07-27
Brief Title:
One Time Injection of Bacteria to Treat Solid Tumors That Have Not Responded to Standard Therapy
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-Refractory Solid Tumor Malignancies
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Design Problem
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will include a one time intravenous IV infusion of Clostridium novyi-NT C novyi-NT spores to treat solid tumors which have not responded to standard therapy
Detailed Description:
Investigators at the SKCCC have developed a bacterial strain C novyi-NT that can infect tumors and destroy them but does not grow in normal tissues In animal experiments a single intravenous injection of these bacteria can cause dramatic regression of many tumors and the tumors do not recur in approximately 30 of the animals
This is a phase I dose escalation study using a single dose of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies The overall objective of this study is to determine the safety and document any preliminary evidence of anti-tumor activity in this patient population
This is a phase I dose escalation study using a single dose of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies The overall objective of this study is to determine the safety and document any preliminary evidence of anti-tumor activity in this patient population
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