Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00703105
Status:
UNKNOWN
Last Update Posted:
2021-04-26
First Post:
2008-06-19
Brief Title:
Ovarian Dendritic Cell Vaccine Trial
Sponsor:
Loyola University
Organization:
Loyola University
Study Overview
Official Title:
Defining the Role of CD4CD25 Immunoregulatory T-cells in the Treatment of Patients With Advanced Ovarian Cancer Who Receive Dendritic Cell Based Vaccine Therapies
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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 purpose of this study is to determine if a dendritic cell vaccine made with autologous tumor lysate or for patients who are HLA-A2 with peptides of MUC1 and WT1 therapy will produce remissions in patients with advanced ovarian cancer This research is being done because we want to find new therapies for treatment of relapsed or refractory resistant to ordinary treatment ovarian cancer The use of vaccine therapy is research
A new experimental approach for treating refractory or relapsed ovarian cancer involves using the patients own immune system to kill the cancer cells These immune cells are called monocytes and are harvested from blood The process of Leukapheresis collects the monocytes called Dendritic Cells This is usually a 3 hour process done in the comfort of a hospital bed in the apheresis lab similar to giving blood for donation Approximately 300ccs are collected during this process the equivalent of about 10 ounces of blood Once these dendritic cells are collected - a special laboratory grows and processes them into a vaccine using a patients own tumor cells or for those with a specific HLA type HLA-A2 with tumor peptides This preparation is then given back to the patient hopefully to stimulate the immune system to kill cancer cells This type of treatment is considered biological research
A new experimental approach for treating refractory or relapsed ovarian cancer involves using the patients own immune system to kill the cancer cells These immune cells are called monocytes and are harvested from blood The process of Leukapheresis collects the monocytes called Dendritic Cells This is usually a 3 hour process done in the comfort of a hospital bed in the apheresis lab similar to giving blood for donation Approximately 300ccs are collected during this process the equivalent of about 10 ounces of blood Once these dendritic cells are collected - a special laboratory grows and processes them into a vaccine using a patients own tumor cells or for those with a specific HLA type HLA-A2 with tumor peptides This preparation is then given back to the patient hopefully to stimulate the immune system to kill cancer cells This type of treatment is considered biological research
Detailed Description:
Patients with advanced ovarian carcinoma who have failed initial curative chemotherapy attempts will be evaluated at the time of relapse for tumor debulking surgery prior to the initiation of salvage chemotherapy If appropriate samples will be collected for tumor lysate preparation for vaccination as per the existing Loyola protocol Lysates may also be produced by the collection of malignant effusions as performed for palliation of symptoms Patients will then receive palliative chemotherapy to a maximum tumor cytoreduction Patients from whom sufficient tumor cells have been collected for DC-based vaccine production will undergo a leukapheresis for DC cell production Once completed these patients will receive a DC vaccination with 1 x 106 tumor lysate and KLH-loaded immature DCs into inguinal nodes identified by ultrasound guidance for a total of three injections at two week intervals or for those who are HLA-A2 restricted with pharmaceutical grade MUC1 and WT1 tumor peptides
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