Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

• Status: Active, not recruiting
• Trial end date: 2022-11-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide; Vaccines

Criteria

Inclusion Criteria:

• 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, primitive neuroectodermal tumor (PNET) variants are excluded; grade 4 oligodendrogliomas or oligoastrocytomas are specifically excluded

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

• 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

• Ability to understand and willingness to sign a written informed consent

• Willing to return to Mayo Clinic Rochester for follow-up

• 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

• Achieved a gross total or sub-total resection at time of surgery

Exclusion Criteria:

• 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 magnetic resonance imaging (MRI) scans performed (e.g. cardiac pacemaker-dependent)