Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
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.
- Rochester, Minnesota: 13-000808
NCT ID: NCT01957956
Sponsor Protocol Number: MC1272
About this study
This pilot clinical trial studies vaccine therapy and temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy and temozolomide may be an effective treatment for glioblastoma.
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
- Enhancing intracranial mass on magnetic resonance imaging (MRI) compatible with glioblastoma
- Planned craniotomy and resection of tumor
- Ability to understand and willingness to sign a written informed consent
- Willing to return to Mayo Clinic Rochester for follow-up
- Willing and capable of undergoing apheresis for collection of mononuclear cells
- Histologically confirmed GBM (grade 4 astrocytoma) NOTE: gliosarcomas and other grade 4 astrocytoma variants (e.g., giant cell) may be included; grade 4 oligodendrogliomas or oligoastrocytomas are specifically excluded
- Class I major histocompatibility complex haplotype human leukocyte antigen (HLA)-A*0201 confirmed by standard haplotyping
- Karnofsky Performance Score ≥ 70
- Absolute neutrophil count (ANC) ≥ 1500 / uL
- Platelets (PLT) ≥ 100,000 / uL
- Hemoglobin (HgB) ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x upper normal limit (UNL)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 3 x UNL
- Creatinine ≤ 1 x UNL
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
- Willing to provide tissue and blood samples for mandatory correlative research purposes
- Fixed or decreasing dose of corticosteroids (or no corticosteroids) ≥ 7 days prior to registration
- Completed standard external beam radiation with temozolomide
- Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents
- Any of the following
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis B (HepB), or hepatitis C (HepC) positive
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- History of other malignancy including treated lower grade gliomas; EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or lower grade glioma that has never been treated previously; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- History of myocardial infarction ≤ 180 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Active infection ≤ 5 days prior to registration or fever > 38 degrees Celsius (C) on day of registration
- History of tuberculosis or positive purified protein derivative (PPD) test
- Inability or unwillingness to have MRI scans performed (e.g. cardiac pacemaker-dependent)
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Ian Parney, M.D., Ph.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office