Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027131
Status:
TERMINATED
Last Update Posted:
2008-10-08
First Post:
2001-11-27
Brief Title:
Vaccination Against High Risk Breast Cancer Using Tumor Derived Heat Shock Protein 70
Sponsor:
UConn Health
Organization:
UConn Health
Study Overview
Official Title:
Vaccination Against High Risk Breast Cancer With Autologous Tumor-Derived Heat Shock Protein 70-Peptide Complexes HSP70
Status:
TERMINATED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty with accrual
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Description The trial is designed to determine the response of the immune system of patients with breast cancer to a vaccine made from their own tumor Researchers believe that this particular vaccine which is made from purified heat shock proteins taken from each patients tumor might alert the bodys immune system to recognize and attack invading cancer To be considered potentially eligible for this study you must be a high risk breast cancer patient and have a tumor that can be removed surgically
LengthDuration Vaccinations are administered weekly for six weeks Follow up visits to the clinic are every three months for two years then every six months thereafter
LengthDuration Vaccinations are administered weekly for six weeks Follow up visits to the clinic are every three months for two years then every six months thereafter
Detailed Description:
Heat-shock proteins HSP are present within normal and cancerous cells They are among the most ancient molecules in evolution and are known as protein chaperones because of their abilities to bind polypeptide chains to assist in protein folding transport or turnover Works pioneered by Srivastavas group Srivastava et al 1998 have shown that HSPs can associate non-covalently with antigenic peptides Injection of HSP-peptide complexes isolated from tumor cells can induce tumor protection against both pre-established tumors and subsequent tumor challenge by eliciting specific cytotoxic T lymphocyte CTL response against a variety of tumors in animals such as sarcoma lymphoma melanoma hepatoma prostate cancer and lung cancer Tamura et al
A previous trial on the role of HSP70 in breast cancer treatment was targeted specifically against patients who had widespread metastasis and who had failed all conventional therapy including intensive multi-agent chemotherapy with DTEC decadron taxol etoposide and cyclophosphamide
This pilot study has shown that 1 HSP70 can be purified successfully from breast cancer cells 2 The yield of HSP70 is extremely variable and cannot be predicted accurately based on the size of the tumor because of significant heterogeneity of histology and patients prior history of chemotherapy 3 HSP70 vaccination is safe and well tolerated
Hypothesis and current protocol
The biggest challenge of cancer management is to control metastasis It is perhaps more obvious in breast cancer than in any other tumor Breast cancer patients rarely die of primary cancer The tendency of a deadly relapse in distal sites after years of remission is the common cause of mortality Even with newly diagnosed patients who present with stage IV breast cancer complete response can be achieved in more than 40 of patients with the current multi-modality approach However patients with stage IV breast cancer are never cured because of the risk of late relapses
There are several reasons for the unsatisfactory results of immunotherapy in advanced and widespread cancers First the tumor burden is too overwhelming Host defenses are simply over powered Second patients at this stage usually have significant co-morbidities which prevent optimal immune responses Third advanced cancer patients often have a compromised functional state of the immune system either quantitatively or qualitatively due to prior cytotoxic therapy radiation therapy or as a result of active secretion of immunosuppressive agents by the tumor cells such as TGF-beta Finally there is simply not enough time to mount an effective adaptive immune response in these patients
Therefore we hypothesize that immunotherapy with HSP70 is more effective as consolidation therapy for high-risk patients who are rendered to have only minimal residue disease To test this hypothesis tumors from patients with high-risk breast cancer will be resected for HSP70 purification This will be followed by conventional therapy such as hormonal therapy chemotherapy radiation therapy or combined modality treatment A total of 15 patients who are either in complete remission or in stable partial remission after standard therapy will be enrolled to test the hypothesis that HSP70 vaccine will lead to improved tumor-specific T cell response in over 40 of patients As a secondary endpoint it will be determined whether the immunological responses can be correlated with disease-free survival or progression-free survival
A previous trial on the role of HSP70 in breast cancer treatment was targeted specifically against patients who had widespread metastasis and who had failed all conventional therapy including intensive multi-agent chemotherapy with DTEC decadron taxol etoposide and cyclophosphamide
This pilot study has shown that 1 HSP70 can be purified successfully from breast cancer cells 2 The yield of HSP70 is extremely variable and cannot be predicted accurately based on the size of the tumor because of significant heterogeneity of histology and patients prior history of chemotherapy 3 HSP70 vaccination is safe and well tolerated
Hypothesis and current protocol
The biggest challenge of cancer management is to control metastasis It is perhaps more obvious in breast cancer than in any other tumor Breast cancer patients rarely die of primary cancer The tendency of a deadly relapse in distal sites after years of remission is the common cause of mortality Even with newly diagnosed patients who present with stage IV breast cancer complete response can be achieved in more than 40 of patients with the current multi-modality approach However patients with stage IV breast cancer are never cured because of the risk of late relapses
There are several reasons for the unsatisfactory results of immunotherapy in advanced and widespread cancers First the tumor burden is too overwhelming Host defenses are simply over powered Second patients at this stage usually have significant co-morbidities which prevent optimal immune responses Third advanced cancer patients often have a compromised functional state of the immune system either quantitatively or qualitatively due to prior cytotoxic therapy radiation therapy or as a result of active secretion of immunosuppressive agents by the tumor cells such as TGF-beta Finally there is simply not enough time to mount an effective adaptive immune response in these patients
Therefore we hypothesize that immunotherapy with HSP70 is more effective as consolidation therapy for high-risk patients who are rendered to have only minimal residue disease To test this hypothesis tumors from patients with high-risk breast cancer will be resected for HSP70 purification This will be followed by conventional therapy such as hormonal therapy chemotherapy radiation therapy or combined modality treatment A total of 15 patients who are either in complete remission or in stable partial remission after standard therapy will be enrolled to test the hypothesis that HSP70 vaccine will lead to improved tumor-specific T cell response in over 40 of patients As a secondary endpoint it will be determined whether the immunological responses can be correlated with disease-free survival or progression-free survival
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