Viral Therapy in Treating Patients with Recurrent Glioblastoma Multiforme


About this study

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of viral therapy in treating patients with recurrent glioblastoma multiforme.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • PLT ≥ 100,000/uL
  • Must have central review prior to registration
  • Candidate for gross total or subtotal resection
  • Ability to provide informed consent
  • Willing to provide biological specimens as required by the protocol
  • Normal serum CEA level (< ng/ml) at the time of registration
  • Recurrent grade 4 astrocytoma and grade 4 gliosarcoma with histological confirmation at primary diagnosis and/or recurrence
  • Negative serum pregnancy test done ≤ 7 days prior to registration (for women of childbearing potential only)
  • Anti-measles virus immunity as demonstrated by IgG anti-measles antibody levels of ≥ 20 EU/ml as determined by Enzyme Immunoassay
  • Grade 3 astrocytoma patients with clinical or imaging characteristics suggestive of progression to grade 4 are eligible, provided that the diagnosis of grade 4 astrocytoma is confirmed by biopsy (including confirmation in frozen section) prior to viral administration
  • Total bilirubin ≤ 1.5 x upper normal limit (ULN)
  • AST ≤ 2 x ULN
  • Creatinine ≤ 2.0 x ULN
  • Hgb ≥ 9.0 gm/dL
  • PT and aPTT ≤ 1.3 x ULN
  • ECOG performance status (PS) 0, 1 or 2
  • ANC ≥ 1500/uL

Exclusion Criteria:

  • Pregnant women
  • Nursing women
  • 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 IV
  • Requiring blood product support
  • Inadequate seizure control
  • Expected communication between ventricles and resection cavity as a result of surgery
  • History of organ transplant
  • History of chronic hepatitis B or C
  • Exposure to household contact ≤ 15 months old or household contact with known immunodeficiency
  • Allergy to measles vaccine or history of severe reaction to prior measles vaccination
  • Chemotherapy ≤ 4 weeks prior to registration (6 wks for nitrosourea-based chemotherapy)
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA -approved indication and in the context of research investigation)
  • History of tuberculosis or history of PPD positivity
  • Biologic therapy ≤ 4 weeks prior to registration
  • Non-cytotoxic antitumor drugs (i.e., small molecular cell cycle inhibitors) ≤ 2 weeks prior to registration
  • HIV-positive test result or history of other immunodeficiency
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Active infection ≤ 5 days prior to registration
  • Immunotherapy ≤ 4 weeks prior to registration

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Evanthia Galanis, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions