Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme
This trial is active, not recruiting.
|Condition||recurrent central nervous system neoplasm|
|Treatment||btsc mrna-loaded dcs|
|Collaborator||National Cancer Institute (NCI)|
|Start date||September 2009|
|End date||July 2016|
|Trial size||50 participants|
|Trial identifier||NCT00890032, CDR0000630701, P30CA014236, Pro00006677, R01CA135272|
RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients undergoing surgery for recurrent glioblastoma multiforme (GBM).
|Intervention model||single group assignment|
Feasibility and safety
time frame: 12 months
Humoral and cellular immune responses
time frame: 12 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Age >18 years of age - First recurrence of GBM (WHO Grade IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of GBM - No known contraindications to receiving Avastin - Karnofsky Performance Status (KPS) of > 70% - Radiation Therapy (RT) with ≥ 45 Gy tumor dose, completed ≥ 8 weeks prior to study entry Exclusion Criteria: - Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal) - Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment - Pregnant or need to breast feed during the study period (Negative beta-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study - Active infection requiring treatment or an unexplained febrile (> 101.5 degrees F) illness - Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus infection, Hepatitis B or Hepatitis C - Unstable or severe intercurrent medical conditions such as severe heart (New York Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled diabetes mellitus - Prior brachytherapy, carmustine wafer therapy, radiolabeled monoclonal antibodies, or stereotactic radiosurgery - Prior inguinal lymph node dissection Avastin-Specific Exclusion Criteria Subjects meeting any of the following criteria are ineligible for study entry: - Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg) - Prior history of hypertensive crisis or hypertensive encephalopathy - New York Heart Association (NYHA) Grade II or greater congestive heart failure - History of myocardial infarction or unstable angina within 6 months prior to enrollment - History of stroke or transient ischemic attack within 6 months prior to enrollment - Significant vascular disease (e.g. aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) (within 6 months prior to enrollment) - History of hemoptysis (> or = 1/2 teaspoon of bright red blood per episode) within 28 days prior to enrollment - Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment - Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment - Serious, non-healing wound, active ulcer or untreated bone fracture - Proteinuria as defined by > +1 on urinalysis dipstick - Known hypersensitivity to any component of Avastin - Pregnant (positive pregnancy test) or lactation
|Official title||Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial|
|Principal investigator||Gordana Vlahovic, MD|
|Description||OBJECTIVES: Primary - To evaluate the feasibility and safety of an autologous brain tumor stem cell messenger ribonucleic acid (mRNA)-loaded dendritic cell vaccine in adult patients with recurrent glioblastoma multiforme. Secondary - To assess humoral and cellular immune responses to vaccination. - To compare the proportion of vaccinated patients alive at 6 months from the time of surgery for recurrent tumor with matched historical cohorts. OUTLINE: Patients undergo surgical resection of tumor. Tumor tissue samples are collected to isolate brain tumor stem cells (BTSCs) and for extraction and amplification of BTSC-specific mRNA. Within 4 weeks after surgical resection, patients undergo leukapheresis over 4 hours to generate dendritic cells (DCs). Patients also undergo leukapheresis at 1 week after the third vaccination and then at least every 3 months as needed for generation of additional DCs. Patients receive autologous BTSC mRNA-loaded DC vaccine intradermally once weekly for 3 weeks and then once monthly in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.|
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