Status:
COMPLETED
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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, c...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- Recurrent grade 3 or 4 glioma, including astrocytoma, oligodendroglioma or mixed glioma with histologic confirmation at initial diagnosis or recurrence
- Candidate for gross total or subtotal resection
- Absolute neutrophil count (ANC) \>= 1500/uL
- Platelets (PLT) \>= 100,000/uL
- Total bilirubin =\< 1.5 x upper normal limit (ULN)
- Aspartate aminotransferase (AST) =\< 2 x ULN
- Creatinine =\< 2.0 x ULN
- Hemoglobin (Hgb) \>= 9.0 gm/dL
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.3 x ULN
- Ability to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Anti-measles virus immunity as demonstrated by immunoglobulin G (IgG) anti-measles antibody levels of \>= 1.1 EU/ml as determined by enzyme immunoassay
- Normal serum CEA levels (\< 3 ng/ml) at the time of registration
- Willing to provide biologic specimens as required by the protocol
- Negative serum pregnancy test done =\< 7 days prior to registration (for women of childbearing potential only)
Exclusion
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Active infection =\< 5 days prior to registration
- History of tuberculosis or history of purified protein derivative (PPD) positivity
- Any of the following therapies:
- Chemotherapy =\< 4 weeks prior to registration (6 wks for nitrosourea-based chemotherapy)
- Immunotherapy =\< 4 weeks prior to registration
- Biologic therapy =\< 4 weeks prior to registration
- Bevacizumab =\< 12 weeks prior to registration
- Non-cytotoxic antitumor drugs, i.e., small molecule cell cycle inhibitors =\< 2 weeks prior to registration
- Radiation therapy =\< 6 weeks prior to registration
- Any viral or gene therapy prior to registration
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
- New York Heart Association classification III or IV
- Requiring blood product support
- Inadequate seizure control
- Expected communication between ventricles and resection cavity as a result of surgery
- Human immunodeficiency virus (HIV)-positive test result, or history of other immunodeficiency
- History of organ transplantation
- History of chronic hepatitis B or C
- Other concurrent chemotherapy, immunotherapy, radiotherapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
- Exposure to household contacts =\< 15 months old or household contact with known immunodeficiency
- Allergy to measles vaccine or history of severe reaction to prior measles vaccination
Key Trial Info
Start Date :
October 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00390299
Start Date
October 23 2006
End Date
November 30 2019
Last Update
January 2 2020
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905