Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03412786
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2018-01-02
Brief Title:
Bcl-XL_42-CAF09b Vaccination for Patients With Prostate Cancer With Lymph Node Metastases
Sponsor:
Herlev Hospital
Organization:
Herlev Hospital
Study Overview
Official Title:
A Phase I Study of the Bcl-XL_42-CAF09b Vaccine to Test Safety and Immunological Effect in Patients With Prostate Cancer With Lymph Node Metastases
Status:
COMPLETED
Status Verified Date:
2022-01
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:
In this Phase I study patients with hormone-sensitive Prostate Cancer PC and lymph node metastases are treated with the cancer vaccine Bcl-xl_42-CAF09b The aim of the study is to clarify the safety and toxicity of the vaccine and also the immunological effect
The vaccine Bcl-xl_42-CAF09b is composed of the peptide Bcl-xl_42 and the adjuvant CAF09b The B-cell lymphoma extra large protein Bcl-xl protein plays a vital role in the cancer cells ability to avoid programmed cell death apoptosis and is upregulated in a variety of cancerous diseases Bcl-xl_42 is a peptide fragment of the full protein and preclinical studies have shown that vaccination with this peptide Bcl-xl can activate the immune system and thereby lead to the death of cancer cells In order to improve the activation of the immune system adjuvant CAF09b is added Preclinical studies have shown that special intraperitoneal IP injections of CAF09b improve the activation of the immune system
The vaccine Bcl-xl_42-CAF09b is composed of the peptide Bcl-xl_42 and the adjuvant CAF09b The B-cell lymphoma extra large protein Bcl-xl protein plays a vital role in the cancer cells ability to avoid programmed cell death apoptosis and is upregulated in a variety of cancerous diseases Bcl-xl_42 is a peptide fragment of the full protein and preclinical studies have shown that vaccination with this peptide Bcl-xl can activate the immune system and thereby lead to the death of cancer cells In order to improve the activation of the immune system adjuvant CAF09b is added Preclinical studies have shown that special intraperitoneal IP injections of CAF09b improve the activation of the immune system
Detailed Description:
Background
In this Phase I study patients with hormone-sensitive Prostate Cancer PC and lymph node metastases are treated with the cancer vaccine Bcl-xl_42-CAF09b The aim of the study is to clarify the safety and toxicity of the vaccine and also the immunological effect
Patients included should be on Bicalutamid treatment upon inclusion The vaccine Bcl-xl_42-CAF09b is composed of the peptide Bcl-xl_42 and the adjuvant CAF09b The B-cell lymphoma extra large protein Bcl-xl protein plays a vital role in the cancer cells ability to avoid programmed cell death apoptosis and is upregulated in a variety of cancerous diseases Bcl-xl_42 is a peptide fragment of the full protein and preclinical studies have shown that vaccination with this peptide Bcl-xl can activate the immune system and thereby lead to the death of cancer cells
In order to improve the activation of the immune system adjuvant CAF09b is added Preclinical studies have shown that special intraperitoneal IP injections of CAF09b improve the activation of the immune system
The CAF09 adjuvant has been developed by Statens Serum Institut SSI It is a three-component adjuvant system composed of cationic liposomes DDA-MMG1 with complex bound synthetic double-stranded RNA PolyIC2 The adjuvant was developed as a means to induce cytotoxic CD8 T-cell responses against vaccine antigens and intended for use in vaccines against disease targets such as cancers human immunodeficiency virus or Hepatitis C virus The PolyIC component has previously been in clinical studies as a cancer treatment PolyIC is known for its pyrogenic activity but upon formulation in the cationic liposome system CAF09 the pyrogenic effect is significantly reduced
Methods
20 patients will be included in this phase I trial 10 patients will be included in arm A and 10 patients in arm B Arm a will recieve 3 vaccines every second week IM and thereafter 3 vaccines every second week IP Arm B will first receive 3 vaccines every second week IP and thereafter every second week IM All 20 patients will recieve 6 vaccines all in all This is not randomized - the first 10 patients included will be in arm A and the last 10 patients included will be in arm B
Patients will be followed with clinical controls every second week
In this Phase I study patients with hormone-sensitive Prostate Cancer PC and lymph node metastases are treated with the cancer vaccine Bcl-xl_42-CAF09b The aim of the study is to clarify the safety and toxicity of the vaccine and also the immunological effect
Patients included should be on Bicalutamid treatment upon inclusion The vaccine Bcl-xl_42-CAF09b is composed of the peptide Bcl-xl_42 and the adjuvant CAF09b The B-cell lymphoma extra large protein Bcl-xl protein plays a vital role in the cancer cells ability to avoid programmed cell death apoptosis and is upregulated in a variety of cancerous diseases Bcl-xl_42 is a peptide fragment of the full protein and preclinical studies have shown that vaccination with this peptide Bcl-xl can activate the immune system and thereby lead to the death of cancer cells
In order to improve the activation of the immune system adjuvant CAF09b is added Preclinical studies have shown that special intraperitoneal IP injections of CAF09b improve the activation of the immune system
The CAF09 adjuvant has been developed by Statens Serum Institut SSI It is a three-component adjuvant system composed of cationic liposomes DDA-MMG1 with complex bound synthetic double-stranded RNA PolyIC2 The adjuvant was developed as a means to induce cytotoxic CD8 T-cell responses against vaccine antigens and intended for use in vaccines against disease targets such as cancers human immunodeficiency virus or Hepatitis C virus The PolyIC component has previously been in clinical studies as a cancer treatment PolyIC is known for its pyrogenic activity but upon formulation in the cationic liposome system CAF09 the pyrogenic effect is significantly reduced
Methods
20 patients will be included in this phase I trial 10 patients will be included in arm A and 10 patients in arm B Arm a will recieve 3 vaccines every second week IM and thereafter 3 vaccines every second week IP Arm B will first receive 3 vaccines every second week IP and thereafter every second week IM All 20 patients will recieve 6 vaccines all in all This is not randomized - the first 10 patients included will be in arm A and the last 10 patients included will be in arm B
Patients will be followed with clinical controls every second week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None