Recurrent Glioblastoma Clinical Trial
Official title:
Phase I Trial of a Measles Virus Derivative Producing CEA (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme (GBM)
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.
PRIMARY OBJECTIVES:
I. To assess the safety and toxicity of intratumoral and resection cavity administration of
an Edmonston's 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 shedding/persistence 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.
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