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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00390299 |
RATIONALE: The measles virus, that has been changed in a certain way, may kill tumor cells without damaging normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of viral therapy in treating patients with recurrent glioblastoma multiforme.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: carcinoembryonic antigen-expressing measles virus Genetic: fluorescence in situ hybridization Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: conventional surgery Procedure: needle biopsy Procedure: neoadjuvant therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of a Measles Virus Derivative Producing CEA (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme (GBM) |
Estimated Enrollment: | 40 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 sequential treatment groups.
In both groups, cohorts of 1-6 patients receive escalating doses of MV-CEA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD in group 1 has been determined, patients are assigned to group 2. The MTD in group 1 is used to determine the starting dose in group 2. At least 10 patients are treated at the MTD determined in group 2.
Biopsy specimen, resected tumor, normal tissue, and peripheral blood are collected during study for immunologic and biomarker correlative studies, including analysis of CD46 receptor levels (by immunohistochemistry [IHC]), measles virus N protein (by IHC), measles and viral gene expression and replication (by in situ hybridization), CEA monitoring (by immunoassay), measles virus N mRNA (by reverse transcriptase-polymerase chain reaction), and measles virus immunity. Assessments of immune competence and peripheral response to viral administration are also performed.
After completion of study treatment, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Candidate for gross total or subtotal resection
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Evanthia Galanis, MD | Mayo Clinic |
Investigator: | Jan C. Buckner, MD | Mayo Clinic |
Investigator: | Brian P. O'Neill, MD | Mayo Clinic |
Investigator: | Corey Raffel, MD | Mayo Clinic |
Investigator: | Frederic B. Meyer, MD | Mayo Clinic |
Investigator: | John L.D. Atkinson, MD | Mayo Clinic |
Investigator: | Richard W. Marsh, MD | Mayo Clinic |
Investigator: | David G. Piepgras, MD | Mayo Clinic |
Investigator: | Timothy Kaufmann, MD | Mayo Clinic |
Investigator: | Gregory A. Poland, MD | Mayo Clinic |
Study ID Numbers: | CDR0000507615, MAYO-MC0671, MAYO-06-004440 |
Study First Received: | October 18, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00390299 History of Changes |
Health Authority: | Unspecified |
recurrent adult brain tumor adult glioblastoma adult gliosarcoma adult giant cell glioblastoma |
Glioblastoma Astrocytoma Measles Adjuvants, Immunologic Central Nervous System Neoplasms Recurrence Virus Diseases Brain Neoplasms |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioblastoma Multiforme Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |