Ignite Creation Date:
2024-05-06 @ 2:26 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02046174
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2014-01-21
Brief Title:
Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared to Best Supportive Care in Colorectal Cancer Patients
Sponsor:
The Rogosin Institute
Organization:
The Rogosin Institute
Study Overview
Official Title:
A Phase IIb Nonrandomized Open-Label Trial With Mouse Renal Adenocarcinoma RENCA Cell Containing Agarose-Agarose Macrobeads Compared With Best Supportive Care in Patients With Treatment-Resistant Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2021-02
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:
This is a clinical research study of an investigational FDA IND-BB 10091 treatment for patients with advanced colorectal cancer that no longer responds to standard therapies
The treatment is being evaluated for its effect on tumor growth It consists of the placement implantation of small beads that contain mouse renal adenocarcinoma cells RENCA macrobeads The cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients It has been tested in 31 human subjects with different types of cancers in a Phase I safety trial Phase II studies in patients with colorectal pancreatic or prostate cancers are in progress
The treatment is being evaluated for its effect on tumor growth It consists of the placement implantation of small beads that contain mouse renal adenocarcinoma cells RENCA macrobeads The cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients It has been tested in 31 human subjects with different types of cancers in a Phase I safety trial Phase II studies in patients with colorectal pancreatic or prostate cancers are in progress
Detailed Description:
This is a Phase IIb multicenter nonrandomized open-label study with RENCA macrobeads in patients with treatment-resistant metastatic colorectal carcinoma to determine the effect of RENCA macrobead implantation on overall survival compared with best supportive care
Two treatment groups will be enrolled in this study as follows
Group A n40 - patients who will undergo up to 4 implantations of RENCA macrobeads no less than 3 months apart at a dosage level of 8 RENCA macrobeads per kilogram of body weight
Group B n80 - patients who had previously decided independently of this study to receive or continue receiving best supportive care defined as management of symptoms aimed at maintaining or improving quality of life but not including approved therapies targeting the patients malignancy
Two treatment groups will be enrolled in this study as follows
Group A n40 - patients who will undergo up to 4 implantations of RENCA macrobeads no less than 3 months apart at a dosage level of 8 RENCA macrobeads per kilogram of body weight
Group B n80 - patients who had previously decided independently of this study to receive or continue receiving best supportive care defined as management of symptoms aimed at maintaining or improving quality of life but not including approved therapies targeting the patients malignancy
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 |
|---|---|---|---|
| 1310014396 | OTHER | Weill Cornell Medical College IRB | None |