Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365937
Status:
TERMINATED
Last Update Posted:
2019-03-06
First Post:
2006-08-17
Brief Title:
Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New regulatories of the peptides by the pharmaceutical company the seller
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open-label single center study Patients will be divided in four groups of 7 Group 1 8 melanoma-specific peptides in saline Group 2 same mix of peptides Montanide ISA51 Group 3 same mix of peptides IMP321 500 µg Group 4 same mix of peptides IMP321 500 µg Montanide ISA51 These vaccines will be administered every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections
Detailed Description:
Open-label single center study Patients will be divided in four groups of 7 The patients will be entered sequentially at the time they present in clinic and randomized in one of the four groups
The first group of patients will receive a dose of 300 µg of each of the MAGE-1A2 MAGE-3A2 MAGE-4A2 MAGE-10A2 MAGE-C2A2 NA17A2 TyrosinaseA2 and NY-ESO-1A2 peptides without adjuvant The peptides will be mixed together and administered by intradermal and superficial subcutaneous injections at two sites every three weeks on 5 occasions 3 months
The second group of patients will receive on 5 occasions a vaccine containing the same 8 peptides mixed together but emulsified in 1 ml of Montanide ISA51 This vaccine will be also administered by intradermal and subcutaneous injections every three weeks
The third cohort of patients will receive at 3 weeks-interval on 5 occasions the mix of 8 peptides and 500 µg of IMP321 These two injections will be done at the same site first adjuvant IMP321 then the peptides
The last seven patients will receive as vaccine the same mix of peptides emulsified with Montanide ISA 51 VG and IMP321 injected with the same procedure as cohort 3 These vaccines will be administrated every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections
Blood samples will be obtained from a buffy-coat at weeks 1 and 16 PBL collected at baseline day 1 and at week 16 will be tested to determine whether a specific CTL response defined as a 10-times or more increase in CTL frequency occurred
For the patients with an anti-vaccine lymphocyte response 100 ml of blood will be collected every three months in order to monitor their immune response If a decrease in CTL frequency by a factor 10 is observed the patients will be revaccinated three times at three weeks interval with the peptides against which he developed an immune response mixed with the adjuvant he already received
The disease status will be assessed at study entry and thereafter every 3 months during one year At any time relapse will result in withdrawal of the patient from the trial
The first group of patients will receive a dose of 300 µg of each of the MAGE-1A2 MAGE-3A2 MAGE-4A2 MAGE-10A2 MAGE-C2A2 NA17A2 TyrosinaseA2 and NY-ESO-1A2 peptides without adjuvant The peptides will be mixed together and administered by intradermal and superficial subcutaneous injections at two sites every three weeks on 5 occasions 3 months
The second group of patients will receive on 5 occasions a vaccine containing the same 8 peptides mixed together but emulsified in 1 ml of Montanide ISA51 This vaccine will be also administered by intradermal and subcutaneous injections every three weeks
The third cohort of patients will receive at 3 weeks-interval on 5 occasions the mix of 8 peptides and 500 µg of IMP321 These two injections will be done at the same site first adjuvant IMP321 then the peptides
The last seven patients will receive as vaccine the same mix of peptides emulsified with Montanide ISA 51 VG and IMP321 injected with the same procedure as cohort 3 These vaccines will be administrated every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections
Blood samples will be obtained from a buffy-coat at weeks 1 and 16 PBL collected at baseline day 1 and at week 16 will be tested to determine whether a specific CTL response defined as a 10-times or more increase in CTL frequency occurred
For the patients with an anti-vaccine lymphocyte response 100 ml of blood will be collected every three months in order to monitor their immune response If a decrease in CTL frequency by a factor 10 is observed the patients will be revaccinated three times at three weeks interval with the peptides against which he developed an immune response mixed with the adjuvant he already received
The disease status will be assessed at study entry and thereafter every 3 months during one year At any time relapse will result in withdrawal of the patient from the trial
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