Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145145
Status:
TERMINATED
Last Update Posted:
2022-10-07
First Post:
2005-09-01
Brief Title:
Immunization With the MAGE-3A1 Peptide Mixed With the Adjuvant CpG 7909 in Patients With Metastatic Melanoma
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Phase III Study of Immunization With the MAGE-3A1 Peptide Mixed With the Immunological Adjuvant CpG 7909 in Patients With Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to determine whether immunization with the MAGE-3A1 peptide mixed with CpG 7909 results in a detectable immune response to determine the safety of this vaccine and to document the tumor response to the vaccine
Detailed Description:
Patients will be vaccinated every two weeks on six occasions On each vaccination day the MAGE-3A1 peptide 300 µg mixed with CpG 7909 5 mg will be administered twice intradermally 10 of the dose each and twice subcutaneously 40 of the dose each in the arms and thighs
Tumor staging will be performed before inclusion and at week 13 PBL collections will be performed before starting the treatment and at weeks 3 7 and 13 They will provide the T lymphocytes for the immunological analysis
Additional cycles of immunization will be proposed to patients without tumor progression requiring another treatment A second cycle of 3 injections at 6-week intervals will be started at week 17 with the same vaccine followed by a third cycle of 12 injections at 3-month intervals starting at month 11 At any time progression of the disease necessitating any treatment not allowed during the study will result in study withdrawal
Tumor staging will be performed before inclusion and at week 13 PBL collections will be performed before starting the treatment and at weeks 3 7 and 13 They will provide the T lymphocytes for the immunological analysis
Additional cycles of immunization will be proposed to patients without tumor progression requiring another treatment A second cycle of 3 injections at 6-week intervals will be started at week 17 with the same vaccine followed by a third cycle of 12 injections at 3-month intervals starting at month 11 At any time progression of the disease necessitating any treatment not allowed during the study will result in study withdrawal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None