Clinical trial · Interventional
Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme
Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial
NCT00890032CI-TRIAL-00024305completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Central Nervous System Neoplasm | Central Nervous System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BTSC mRNA-loaded DCs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BTSC mRNA-loaded DCs
- description
- BTSC mRNA-loaded DCs administered intradermally weekly for first 3 vaccines, then monthly until progression or withdrawal.
- interventionNames
- Biological: BTSC mRNA-loaded DCs
Primary outcomes (1)
- measure
- Feasibility and safety
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Humoral and cellular immune responses
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.