Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459069
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2007-04-10
Brief Title:
The Use of Dendritic CellTumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
The Use of Dendritic CellTumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2010-01
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 main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine Cancer cells have unique markers that distinguish them from normal cells of the body These markers can potentially serve as targets for the immune system Dendritic cells are normally found in small amounts in the body and are responsible for immune responses against foreign substances that enter the body Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses
Detailed Description:
To create the study vaccine cells will be removed from the participants tumor and fused mixed with powerful immune system stimulating cells dendritic cells obtained from the participants blood
Not everyone who participates in this study will be receiving the same amount of study vaccine A small group of people will be enrolled into the study and given a certain dose If they tolerate it well the next group of people enrolled will receive a higher dose This will continue until the highest dose level tolerated is determined
Once the screening tests are completed and it is determined the participant is eligible they will undergo some baseline procedures In an effort to make the study vaccine tumor cells and dendritic cells will be collected from the participant Tumor cells may be collected from bone marrow or from a collection of tumor cells called a plasmacytoma A decision will be made based upon the location of the cancer
A bone marrow aspirationbiopsy will be performed during the following time points at screening prior to the first vaccination and at 1 month 3 months and 6 months after the final study vaccination These will be used to assess and follow the participants multiple myeloma
Leukapheresis will be performed to obtain dendritic cells This procedure takes 2 to 4 hours to and involves the collection of a large number of white blood cells Dendritic cells will be generated in the laboratory from white blood cells If not enough white blood cells are collected the participant may be asked to return to the clinic for an additional leukapheresis procedure
Before each vaccine is administered weeks 0 3 6 the following study tests and procedures will be performed skin test blood test physical exam and 24-hour urine collection A physical exam and blood tests will be performed on the weeks when the participant does not receive the vaccine weeks 124578
The study schedule will consist of a fixed dose of the fused mixed cell vaccine under the skin every 3 weeks Each study vaccine will be accompanied by an injection of GM-CSF Participants will receive 2 or more vaccines depending upon the total number of fusion cells made the dose the participant is assigned to receive and their response to the study vaccine
Follow-up after the vaccine treatment is completed will consist of the following blood collection 1 3 and 6 months after final study vaccination bone marrow aspirationbiopsy 1 3 and 6 months after final study vaccination physical exam 1 2 3 4 5 and 6 months after final study vaccination radiologic tumor assessment 1 3 and 6 months after final study vaccination
Not everyone who participates in this study will be receiving the same amount of study vaccine A small group of people will be enrolled into the study and given a certain dose If they tolerate it well the next group of people enrolled will receive a higher dose This will continue until the highest dose level tolerated is determined
Once the screening tests are completed and it is determined the participant is eligible they will undergo some baseline procedures In an effort to make the study vaccine tumor cells and dendritic cells will be collected from the participant Tumor cells may be collected from bone marrow or from a collection of tumor cells called a plasmacytoma A decision will be made based upon the location of the cancer
A bone marrow aspirationbiopsy will be performed during the following time points at screening prior to the first vaccination and at 1 month 3 months and 6 months after the final study vaccination These will be used to assess and follow the participants multiple myeloma
Leukapheresis will be performed to obtain dendritic cells This procedure takes 2 to 4 hours to and involves the collection of a large number of white blood cells Dendritic cells will be generated in the laboratory from white blood cells If not enough white blood cells are collected the participant may be asked to return to the clinic for an additional leukapheresis procedure
Before each vaccine is administered weeks 0 3 6 the following study tests and procedures will be performed skin test blood test physical exam and 24-hour urine collection A physical exam and blood tests will be performed on the weeks when the participant does not receive the vaccine weeks 124578
The study schedule will consist of a fixed dose of the fused mixed cell vaccine under the skin every 3 weeks Each study vaccine will be accompanied by an injection of GM-CSF Participants will receive 2 or more vaccines depending upon the total number of fusion cells made the dose the participant is assigned to receive and their response to the study vaccine
Follow-up after the vaccine treatment is completed will consist of the following blood collection 1 3 and 6 months after final study vaccination bone marrow aspirationbiopsy 1 3 and 6 months after final study vaccination physical exam 1 2 3 4 5 and 6 months after final study vaccination radiologic tumor assessment 1 3 and 6 months after final study vaccination
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