Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485277
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2007-06-08
Brief Title:
A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2 Metastatic Breast Cancer
Sponsor:
Bavarian Nordic
Organization:
Bavarian Nordic
Study Overview
Official Title:
A Phase I Trial of a Fixed Dose of MVA-BN-HER2 Following 1st- or 2nd-Line Chemotherapy for HER-2-Positive Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-09
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:
The current trial BNIT-BR-002 will evaluate the safety and biological activity of a fixed dose of MVA-BN-HER2 with and without Herceptin following 1st- or 2nd-line chemotherapy in patients with Her-2-positive metastatic breast cancer
The intent of vaccination is to induce anti-Her-2 immune responses both antibody and T cell that will then attack the Her-2 expressing tumors and may induce tumor regression or slow progression of disease
The intent of vaccination is to induce anti-Her-2 immune responses both antibody and T cell that will then attack the Her-2 expressing tumors and may induce tumor regression or slow progression of disease
Detailed Description:
MVA-BN-HER2 is a candidate breast cancer immunotherapy product comprised of a highly attenuated non-replicating vaccinia virus MVA-BN engineered to encode a modified form of the Her-2 protein
MVA-BN is a well-characterized clonal strain of modified vaccinia virus Ankara MVA being developed as a smallpox vaccine suitable for use in high-risk eg immunocompromised individuals MVA-BN-derived vectors encoding heterologous antigens are being developed for use as vaccines for infectious diseases such as HIV and for the treatment of cancer A large database exists from safety evaluations in animals and in humans for MVA-BN and MVA-BN-derived vectors
Her-2 is overexpressed in 20-30 of human breast cancers It is an oncogenegrowth factor receptor critical for malignant phenotype of Her-2 expressing tumors It is an immunogenic target and immune responses to this protein have been shown to mediate potent anti-tumor activity in multiple animal models Means to stimulate anti-Her-2 reactivity are now being studied clinically Sponsor collaborators and others have used both Protein and DNA vaccine forms of Her-2 and a safety database is developed and no significant adverse events have resulted from Her-2 directed vaccination
MVA-BN-HER2 encodes a modified form of the Her-2 protein hereinafter referred to as HER2 HER2 contains the extracellular domain of Her-2 but lacks the intracellular cell signaling domain In addition HER2 includes two universal T-cell epitopes from tetanus toxin to facilitate the stimulation of an immune response to Her-2 a self-protein
The current trial BNIT-BR-002 will evaluate the safety and biological activity of a fixed dose of MVA-BN-HER2 with and without Herceptin following 1st- or 2nd-line chemotherapy in patients with metastatic breast cancers which overexpress Her-2
Patients will receive 3 subcutaneous vaccinations at 3 week intervals and have tumor followed by CTMRI imaging and blood drawn for immune function analysis
MVA-BN is a well-characterized clonal strain of modified vaccinia virus Ankara MVA being developed as a smallpox vaccine suitable for use in high-risk eg immunocompromised individuals MVA-BN-derived vectors encoding heterologous antigens are being developed for use as vaccines for infectious diseases such as HIV and for the treatment of cancer A large database exists from safety evaluations in animals and in humans for MVA-BN and MVA-BN-derived vectors
Her-2 is overexpressed in 20-30 of human breast cancers It is an oncogenegrowth factor receptor critical for malignant phenotype of Her-2 expressing tumors It is an immunogenic target and immune responses to this protein have been shown to mediate potent anti-tumor activity in multiple animal models Means to stimulate anti-Her-2 reactivity are now being studied clinically Sponsor collaborators and others have used both Protein and DNA vaccine forms of Her-2 and a safety database is developed and no significant adverse events have resulted from Her-2 directed vaccination
MVA-BN-HER2 encodes a modified form of the Her-2 protein hereinafter referred to as HER2 HER2 contains the extracellular domain of Her-2 but lacks the intracellular cell signaling domain In addition HER2 includes two universal T-cell epitopes from tetanus toxin to facilitate the stimulation of an immune response to Her-2 a self-protein
The current trial BNIT-BR-002 will evaluate the safety and biological activity of a fixed dose of MVA-BN-HER2 with and without Herceptin following 1st- or 2nd-line chemotherapy in patients with metastatic breast cancers which overexpress Her-2
Patients will receive 3 subcutaneous vaccinations at 3 week intervals and have tumor followed by CTMRI imaging and blood drawn for immune function analysis
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