Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317603
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2006-04-21
Brief Title:
Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor GM-CSF in Metastatic Breast Cancer Patients
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Trial of Vaccination With Autologous Lethally Irradiated Breast Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor in Metastatic Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2022-03
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 purpose of this trial is to test the safety of a vaccine made from a patients own breast cancer cells and determine if this vaccine will delay or stop the growth of the cancer The vaccine is made by genetically modifying a patients own tumor cells to secrete granulocyte-macrophage colony-stimulating factor GM-CSF to activate the immune response
Detailed Description:
After the patient has given their consent to participate in the trial a series of tests will be performed to determine if the patient is eligible These tests may take place up to 21 days before the surgery to remove a tumor sample or cancer-containing fluid which will be used to create the vaccines The tumor cells or fluid is then brought to a special certified laboratory where the vaccine is made Specially trained laboratory technicians then use a method known as adenoviral mediated gene transfer which adds a new gene to the cancer cells This gene causes the cells to make GM-CSF a powerful hormone that stimulates the immune system The cells are then given radiation so that they will not grow Participants will start receiving vaccine on day 1 8 15 29 and then every two weeks until the supply of vaccine has run out The amount of the vaccine depends upon the total amount of cells that are obtained from the breast cancer tumor or fluid Each time the patient is vaccinated they will be given injections that will be placed underneath the skin A different place will be used for each injection If there are enough cells from the patients tumor sample the patient will be given an injection of non-transduced irradiated cells the gene was not added These cells will help to measure how the patients immune system is reacting to the tumor cells This is called Delayed-Type Hypersensitivity DTH With vaccine 1 and 5 the patient will also receive a DTH injection Two to three days after the vaccine and DTH injection skin biopsies will be taken of both sites At week 10 in the study treatment or earlier if necessary the patient will have a chest abdomen and pelvic CT scan to determine if the vaccine therapy has had an effect on their disease A brain MRI will be performed if there were any abnormalities on the first brain MRI or if new symptoms have developed Patients may participate in this study until one of the following happens All vaccine created from the tumor has been given to the patient the patients disease worsens the patient experiences an unacceptable andor harmful side effect the patient is unable to follow the study plan or the patients doctor feels it is no longer in the best interest of the patient to continue
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