Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390299
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2006-10-18
Brief Title:
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase I Trial of a Measles Virus Derivative Producing CEA MV-CEA in Patients With Recurrent Glioblastoma Multiforme GBM
Status:
COMPLETED
Status Verified Date:
2019-01
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:
This phase I trial studies the side effects and best dose of carcinoembryonic antigen-expressing measles virus MV-CEA in treating patients with glioblastoma multiforme that has come back A virus called MV-CEA which has been changed in a certain way may be able to kill tumor cells without damaging normal cells
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety and toxicity of intratumoral and resection cavity administration of an Edmonstons strain measles virus genetically engineered to produce CEA MV-CEA in patients with recurrent glioblastoma multiforme
II To determine the maximum tolerated dose MTD of MV-CEA III To characterize viral gene expression at each dose level as manifested by CEA titers
IV To assess viremia viral replication and measles virus sheddingpersistence following intratumoral administration
V To assess humoral and cellular immune response to the injected virus VI To assess in a preliminary fashion antitumor efficacy of this approach
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 2 sequential treatment arms
ARM A RESECTION CAVITY ADMINISTRATION Patients undergo en block resection of their tumor after confirming diagnosis on day 1 followed by MV-CEA administered into the resection cavity
ARM B INTRATUMORAL AND RESECTION CAVITY ADMINISTRATION Patients undergo stereotactic biopsy to confirm the diagnosis and placement of a catheter within the tumor followed by carcinoembryonic antigen-expressing measles virus intratumorally IT through the catheter over 10 minutes on day 1 Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques on day 5 followed by MV-CEA administered around the tumor bed
After completion of study treatment patients are followed up at 28 days non-cohort I patients 7 weeks patients in cohort I only every 2 months until progression every 3 and 12 months after progression and then yearly thereafter for up to 15 years
I To assess the safety and toxicity of intratumoral and resection cavity administration of an Edmonstons strain measles virus genetically engineered to produce CEA MV-CEA in patients with recurrent glioblastoma multiforme
II To determine the maximum tolerated dose MTD of MV-CEA III To characterize viral gene expression at each dose level as manifested by CEA titers
IV To assess viremia viral replication and measles virus sheddingpersistence following intratumoral administration
V To assess humoral and cellular immune response to the injected virus VI To assess in a preliminary fashion antitumor efficacy of this approach
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 2 sequential treatment arms
ARM A RESECTION CAVITY ADMINISTRATION Patients undergo en block resection of their tumor after confirming diagnosis on day 1 followed by MV-CEA administered into the resection cavity
ARM B INTRATUMORAL AND RESECTION CAVITY ADMINISTRATION Patients undergo stereotactic biopsy to confirm the diagnosis and placement of a catheter within the tumor followed by carcinoembryonic antigen-expressing measles virus intratumorally IT through the catheter over 10 minutes on day 1 Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques on day 5 followed by MV-CEA administered around the tumor bed
After completion of study treatment patients are followed up at 28 days non-cohort I patients 7 weeks patients in cohort I only every 2 months until progression every 3 and 12 months after progression and then yearly thereafter for up to 15 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 |
|---|---|---|---|
| P50CA108961 | NIH | Mayo Clinic | httpsreporternihgovquickSearchP50CA108961 |
| NCI-2009-01198 | REGISTRY | None | None |
| MC0671 | OTHER | None | None |
| P30CA015083 | NIH | None | None |