Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02380443
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2015-03-02
Brief Title:
AlloStim Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer
Sponsor:
Mirror Biologics Inc
Organization:
Mirror Biologics Inc
Study Overview
Official Title:
In-Situ Cancer Vaccine Phase IIA Open-Label Study to Assess the Safety of AlloStim Immunotherapy Alone and in Combination With Cryoablation as Third Line Therapy for Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-10
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 single center open label dose frequency escalation study of CryoVax personalized anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with intra-lesional immunotherapy with AlloStim The in-situ in the body cancer vaccine step combines killing a single metastatic tumor lesion by use of cryoablation in order to cause the release of tumor-specific markers to the immune system and then injecting bioengineered allogeneic immune cells AlloStim into the lesion as an adjuvant in order to modulate the immune response and educate the immune system to kill other tumor cells where ever they reside in the body
Detailed Description:
Colorectal cancer CRC ranks as the third most common cancer worldwide Metastasis is the main reason of death in CRC patients The current drugs used to treat colorectal cancer provide important treatment options for patients their limitations including drug resistance poor efficacy and severe side effects Development of new therapeutic strategies for KRAS mutant as well as BRAF mutant tumors are therefore highly needed in order to offer a new category of drug immunotherapy This study targets the population of mCRC patients that have progressed after two lines of chemotherapy and are not eligible for targeted therapies The study will assess six different dosing schedules A standard 3 plus 3 study design will be used The starting frequency for each dosing schedule will be escalated in subsequent groups of patients The study will evaluate safety of increased frequency of AlloStim dosing and anti-tumor effect of the new proposed dose and frequency schedule
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