Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT00715832
Status:
UNKNOWN
Last Update Posted:
2009-08-26
First Post:
2008-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Cancer Vaccine Study for Patients With Metastatic Breast Cancer
Sponsor:
Southern Cancer Center
Organization:
Study Overview
Official Title:
A Phase I Vaccine Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2009-08
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 study uses a molecule or particle that is found only on cancer cells and is unique to cancer cells, as it is not detected on normal tissue. The molecule is known as "oncofetal antigen" or OFA. Because OFA is unique to cancer, the investigators feel OFA could be used to educate the patients' own defenses to more effectively fight the cancer on her own, he or she is harboring. Although investigators found OFA to be present in large concentrations on all cancers, it was found to be especially abundant in breast cancers. Therefore, the investigators feel that this molecule would be a good target for stimulating patient defenses especially against breast cancer cells. To accomplish this, certain defense cells (immune cells) will be washed out from the patients' blood using a machine to which the patient is connected through two small cannulas placed into veins located in the patients' arms. Those cells will be manipulated in the laboratory with artificially engineered OFA. These "reeducated" cells will be injected into the skin of patients. There will be a series of three skin injections in 4 week intervals. It is hoped that this treatment will convert the patients' defenses to a point that effective anti cancer responses will be induced. Effectiveness of the treatment will be monitored with blood tests and assessment of the size of the cancers.
Detailed Description:
The study is an open-label study to assess safety and immune responses to the universal tumor antigen OFA/iLRP. All patients will be immunized with 1 x 107 viable OFA/iLRP-loaded mature, autologous monocyte-derived dendritic cells (DCs). The DC vaccine will be administered intradermally into the proximal medial upper extremity, contralateral to the original site of breast cancer once every month for 3 months. Changes in the tumor will be documented. The patient will remain in the study unless toxicity or adverse side effects require discontinuation following RECIST and CTC guidelines, or if the patient withdraws for any other reason.
Study Oversight
Has Oversight DMC:
True
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?: