Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418574
Status:
TERMINATED
Last Update Posted:
2011-11-24
First Post:
2007-01-04
Brief Title:
Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients
Sponsor:
Menarini Group
Organization:
Menarini Group
Study Overview
Official Title:
A RandomisedDouble Blind Placebo Controlled Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No benefit on primary end point RFS no rationale to collect survival data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIMOSA
Brief Summary:
The purpose of this study is to evaluate the benefit of vaccination with Abagovomab an experimental immunotherapy in ovarian cancer patients The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy
Detailed Description:
Standard initial treatment of ovarian cancer patients includes both surgery and chemotherapy which in the vast majority of cases achieves the disappearance of ovarian cancer lesions This status called clinical remission which means having no evidence of cancer on CT scan or physical examination needs to be carefully follow up in order to confirm the maintenance of the remission status or to early detect if the cancer grows again and then start a new chemotherapy At present no approved therapies exist for the maintenance treatment of patients who achieved the clinical remission
This trial aims to evaluate if the repeated vaccination with Abagovomab creates an immunoresponse which is able to fight the cancer cells thus keeping the remission status as long as possible and help patients live disease-free and longer
Patients who achieve the remission status after chemotherapy will be screened for study participation and if they meet the criteria for inclusion they will start to receive a single subcutaneous injection every 2 weeks for the first 4 doses - induction phase and then every 4 weeks maintenance phase The duration of treatment is up to approximately 4 years or it will be stopped in case relapse occurs
In order to evaluate the real benefit of vaccination the experimental treatment includes Abagovomab the active drug or placebo the vehicle only without drug with a double chance to receive Abagovomab Assignment of Abagovomab or placebo will be done by a computerised system and nobody in the study will know which treatment has been allocated until study end
Patients will be visited every 4 weeks and will undergo CT scan of pelvis and abdomen every 12 weeks in order to confirm the remission status or to early detect if relapse eventually occurs This will be done in blind condition ie without being aware which treatment the patient is going to receive for the first part of the study which is expected to last four years After then the overall status of patient will continue to be monitored by phone contact for additional five years
This trial aims to evaluate if the repeated vaccination with Abagovomab creates an immunoresponse which is able to fight the cancer cells thus keeping the remission status as long as possible and help patients live disease-free and longer
Patients who achieve the remission status after chemotherapy will be screened for study participation and if they meet the criteria for inclusion they will start to receive a single subcutaneous injection every 2 weeks for the first 4 doses - induction phase and then every 4 weeks maintenance phase The duration of treatment is up to approximately 4 years or it will be stopped in case relapse occurs
In order to evaluate the real benefit of vaccination the experimental treatment includes Abagovomab the active drug or placebo the vehicle only without drug with a double chance to receive Abagovomab Assignment of Abagovomab or placebo will be done by a computerised system and nobody in the study will know which treatment has been allocated until study end
Patients will be visited every 4 weeks and will undergo CT scan of pelvis and abdomen every 12 weeks in order to confirm the remission status or to early detect if relapse eventually occurs This will be done in blind condition ie without being aware which treatment the patient is going to receive for the first part of the study which is expected to last four years After then the overall status of patient will continue to be monitored by phone contact for additional five years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-002801-30 | EUDRACT_NUMBER | AGO | None |
| AGO-OVAR 10 | OTHER | None | None |