Clinical trial · Interventional
Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Newly Diagnosed Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Cell Glioblastoma | Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine | Biological | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vaccine therapy and temozolomide)
- description
- COURSE 1: Patients receive temozolomide PO daily on days 1-5. COURSES 2-3: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5. COURSES 4-6: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1. COURSES 7-12: Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Biological: Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Incidence of significant toxicity, defined as grade 3 or higher adverse event that is possibly, probably, or definitely related to treatment measured using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- timeFrame
- Up to 84 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available