Viral Therapy in Treating Patients with Recurrent Glioblastoma Multiforme
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 06-004440
NCT ID: NCT00390299
Sponsor Protocol Number: MC0671
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.
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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
- 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 us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Evanthia Galanis, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office