Ignite Creation Date:
2024-05-05 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00711932
Status:
COMPLETED
Last Update Posted:
2013-09-11
First Post:
2008-07-03
Brief Title:
The Effect of TRA-8 on Ovarian Cancer Tissue
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Death Receptor-Mediated Apoptosis and Therapy Strategies in Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 goal of this study is to determine the apoptosis-inducing efficacy of TRA-8 in patient ovarian cancer tissues using a tissue slice technology In addition we want to evaluate the expression of apoptosis regulatory proteins using multiplex proteomic technology and its correlation with TRA-8-induced cytotoxicity in patient ovarian cancer tissues
Detailed Description:
Ovarian cancer remains highly lethal with an estimated 25580 new cases and 16090 death per year in the US The most common ovarian cancers arise from the surface epithelium of the ovary Approximately 75 of patients with advanced-stage cancer are surgically incurable While chemotherapy is a critical component of treatment the pre-existing and induced chemoresistance of ovarian cancer cells is a major obstacle in treatment of patients with advanced disease Novel strategies to enhance the established therapeutic Defective apoptosis has been proposed as one of the major mechanisms that lead to malignant transformation and resistance to therapeutics Defective apoptosis may result from increased growth stimulation oncogenes decreased growth inhibition tumor suppressor genes or imbalanced apoptosis regulation Alterations of the Bcl-2 family proteins have been reported to be associated with chemotherapy resistance in ovarian cancer cells1 Increased anti-apoptosis protein Bcl-XL may play a role in preventing apoptosis of ovarian cancer cells in response to chemotherapy Conversely high levels of pro-apoptosis protein Bax are associated with a favorable response to therapy The role of these and other apoptotic regulatory proteins in sensitivityresistance mechanisms to chemotherapy in patients ovarian cancer cells are just beginning to be elucidated
Precision cut tumor slices will be prepared from fresh primary ovarian tumor specimens using the Krumdieck tissue slicer followed by ex vivo TRA-8 cytotoxicity assays on the tumor slices Tumor-derived tissue slices may be used immediately in short term assays with no need to isolate or expand tumor cells thus avoiding potential problems in maintaining cell viability or selecting variant cells during tumor dispersion or longer periods of in vitro cell culture Demonstration of TRA-8-induced apoptosis using primary ovarian tumors in ex vivo tumor slice cytotoxicity assays can strengthen the rationale for this therapy in this tumor type and may be used to select patients who would most likely benefit from TRA-8 therapy The sensitivity of ovarian patient tumors to TRA-8 paclitaxel and carboplatin will be evaluated in tumor slice cytotoxicity assays as single agents and in combination Slices from different treatment conditions will be paraffin-embedded or frozen for immunohistochemical evaluation
Precision cut tumor slices will be prepared from fresh primary ovarian tumor specimens using the Krumdieck tissue slicer followed by ex vivo TRA-8 cytotoxicity assays on the tumor slices Tumor-derived tissue slices may be used immediately in short term assays with no need to isolate or expand tumor cells thus avoiding potential problems in maintaining cell viability or selecting variant cells during tumor dispersion or longer periods of in vitro cell culture Demonstration of TRA-8-induced apoptosis using primary ovarian tumors in ex vivo tumor slice cytotoxicity assays can strengthen the rationale for this therapy in this tumor type and may be used to select patients who would most likely benefit from TRA-8 therapy The sensitivity of ovarian patient tumors to TRA-8 paclitaxel and carboplatin will be evaluated in tumor slice cytotoxicity assays as single agents and in combination Slices from different treatment conditions will be paraffin-embedded or frozen for immunohistochemical evaluation
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 |
|---|---|---|---|
| ROI CA 123197-01 | None | None | None |