Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00390299 : Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- 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 Criteria:

- 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00390299      |      Link to official Clinicaltrials.gov listing
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