Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090493
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2004-08-26
Brief Title:
Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
UARK 2003-26 A Pilot Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combination With DTPACE Chemotherapy and Autologous Transplantation in Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-05
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 hope is that the peptide vaccines will stimulate the immune system to attack and kill the myeloma cells The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else
Detailed Description:
This is an experimental treatment that will consist of receiving peptide vaccinations as a shot just under the skin subcutaneous We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else
The peptides are fragments from two tumor proteins called MAGE-A3 and NY-ESO-1 In order to be eligible for the study your myeloma cells must express either MAGE-A3 or NY-ESO-1 and your myeloma must be severe enough to require chemotherapy and stem cell transplantation You must also have the appropriate HLA tissue type
Patients who have MAGE-A3 positive myeloma and are HLA-A0101 or -B35 positive will receive the MAGE-A3 peptide vaccine
Patients who have NY-ESO-1 positive myeloma and are HLA-A0201 will receive the NY-ESO-1 peptide vaccine
Three injections with 300µg per injection in 15mls of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg same site in 05 mls at two-week intervals
Your myeloma cells obtained from a routine bone marrow aspirate will be tested in the laboratory for the presence of MAGE-A3 andor NY-ESO-1 proteins HLA tissue type will be determined by standard methods in our Clinical Laboratory This allows allocation of the correct vaccine to each individual patient
Prior to starting a 6-day course of chemotherapy called DTPACE white blood cells will be collected by a procedure called leukapheresis leukapheresis no1 Your white blood cells will be frozen for the duration of the chemotherapy in order to protect these white blood cells from the harmful effects of chemotherapy After the chemotherapy is given stem cells will be collected by leukapheresis PBSC collection and stored until the time of transplantation After a short period of rest the white blood cells from leukapheresis no1 will be thawed and re-infused This will ensure that you will have white blood cells that are in the best possible condition to respond to the peptide vaccines A set of three vaccinations with the peptides at two-week intervals will follow The hope is that the vaccinations will have generated precious anti-myeloma white blood cells
You will again undergo leukapheresis leukapheresis no2 to collect the anti-myeloma white blood cells which will be frozen in order to protect these precious cells from the chemotherapy drugs that will be infused just before the single or double auto-transplant
A single dose of Melphalan will precede each transplant The stem cells that were collected after DTPACE will be given for the transplants For those receiving two transplants a regimen of thalidomide with dexamethasone will be given for approximately 10 weeks between the two transplants You will stop your thalidomide 28 days before the second transplant
After completion of the transplants the anti-myeloma white blood cells collected with leukapheresis no 2 will be thawed and re-infused These anti-myeloma cells will be boosted by three further peptide vaccinations at two-week intervals
Finally after you have completed these three vaccinations you will undergo another leukapheresis no 3 The anti-myeloma white blood cells collected with leukapheresis no 3 will be frozen and stored for possible future use
Six final vaccines will be given at monthly intervals to further amplify the anti-myeloma white blood cells
The peptides are fragments from two tumor proteins called MAGE-A3 and NY-ESO-1 In order to be eligible for the study your myeloma cells must express either MAGE-A3 or NY-ESO-1 and your myeloma must be severe enough to require chemotherapy and stem cell transplantation You must also have the appropriate HLA tissue type
Patients who have MAGE-A3 positive myeloma and are HLA-A0101 or -B35 positive will receive the MAGE-A3 peptide vaccine
Patients who have NY-ESO-1 positive myeloma and are HLA-A0201 will receive the NY-ESO-1 peptide vaccine
Three injections with 300µg per injection in 15mls of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg same site in 05 mls at two-week intervals
Your myeloma cells obtained from a routine bone marrow aspirate will be tested in the laboratory for the presence of MAGE-A3 andor NY-ESO-1 proteins HLA tissue type will be determined by standard methods in our Clinical Laboratory This allows allocation of the correct vaccine to each individual patient
Prior to starting a 6-day course of chemotherapy called DTPACE white blood cells will be collected by a procedure called leukapheresis leukapheresis no1 Your white blood cells will be frozen for the duration of the chemotherapy in order to protect these white blood cells from the harmful effects of chemotherapy After the chemotherapy is given stem cells will be collected by leukapheresis PBSC collection and stored until the time of transplantation After a short period of rest the white blood cells from leukapheresis no1 will be thawed and re-infused This will ensure that you will have white blood cells that are in the best possible condition to respond to the peptide vaccines A set of three vaccinations with the peptides at two-week intervals will follow The hope is that the vaccinations will have generated precious anti-myeloma white blood cells
You will again undergo leukapheresis leukapheresis no2 to collect the anti-myeloma white blood cells which will be frozen in order to protect these precious cells from the chemotherapy drugs that will be infused just before the single or double auto-transplant
A single dose of Melphalan will precede each transplant The stem cells that were collected after DTPACE will be given for the transplants For those receiving two transplants a regimen of thalidomide with dexamethasone will be given for approximately 10 weeks between the two transplants You will stop your thalidomide 28 days before the second transplant
After completion of the transplants the anti-myeloma white blood cells collected with leukapheresis no 2 will be thawed and re-infused These anti-myeloma cells will be boosted by three further peptide vaccinations at two-week intervals
Finally after you have completed these three vaccinations you will undergo another leukapheresis no 3 The anti-myeloma white blood cells collected with leukapheresis no 3 will be frozen and stored for possible future use
Six final vaccines will be given at monthly intervals to further amplify the anti-myeloma white blood cells
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