Immunotherapy for Glioblastoma.

Overview

  • Study type

    Observational
  • Study IDs

  • 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.
  • Site IRB
    • Rochester, Minnesota: 06-002617
    Sponsor Protocol Number: 06-002617

About this study

This study is being done to:

1. Determine the best method of producing blood cells called "dendritic cells" which one day may be used to treat patients like you.

2. Process, grow and characterize tumors into cell cultures, to educate dendritic cells or the immune system to attack the tumor.

3. Analyze your immune system function.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion criteria:

  • Histopathologically confirmed newly diagnosed or recurrent glioblastoma (WHO grade IV glioma).Pathologic diagnosis will be confirmed by a Mayo Clinic neuropathologist.

  • Age ³ 18 years at time of entry into study and ability to provide informed consent to participate in the study.  Signing of the Mayo Clinic Institutional Review Board approved informed consent form will be required prior to study entry.

  • Patients must be candidates for partial or complete surgical resection of their tumor.

  • Patients may have undergone prior radiation therapy or chemotherapy, but must have recovered from such treatments and the treatment must have concluded at least two weeks prior to study entry.

  • Patients may be on corticosteroids, and their steroid treatment status will be noted in the study data collection.

  • Life expectancy > 3 months.

  • KPS > 70

  • Laboratory testing must demonstrate:

    1. Absolute neutrophil count ³ 1000/l.

    2. Platelet ≥ 100,000/μl.

    3. Hgb ≥ 10 g/dL

      Exclusion criteria:

  • Known or suspected active infection, unexplained febrile illness, acquired or congenital immunodeficiency, autoimmune disease, or severe medical condition.

  • Inability to obtain informed consent.

  • Prior treatment with tumor vaccines.

  • Unable to complete required follow-up for any reason.

Women of childbearing age and pregnant women will not be specifically excluded because there should be no deleterious effect to a fetus from maternal participation in this study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Allan Dietz, Ph.D.

Contact us for the latest status

Contact information:

Ian Parney M.D., Ph.D.

(507)255-3199

Parney.Ian@mayo.edu

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CLS-20309516

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