Clinical trial · Interventional
Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma
NCT01635283CI-TRIAL-00048083completedPhase 2Results postedClinicalTrials.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)
The primary purpose of this phase II clinical trial is to determine the safety and effect on survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a treatment for low-grade glioma patients. Other goals of this study are to determine if the vaccine can cause an immune response against patients' cancer cells and slow the growth of their brain tumors
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Diffuse Astrocytoma | Adult Diffuse Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Mixed Glioma | Adult Mixed Glioma | ONTOLOGY_EXACT | 0.98 |
| Adult Oligoastrocytoma | Oligoastrocytoma | CURATED_BROADER | 0.80 |
| Adult Oligodendroglioma | Adult Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Brain Tumor | Adult Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| tumor lysate-pulsed autologous dendritic cell vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (tumor lysate-pulsed autologous dendritic cells)
- description
- Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.
- interventionNames
- Biological: tumor lysate-pulsed autologous dendritic cell vaccine
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
- timeFrame
- Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.
- description
- a Kaplan-Meier curve of the PFS of our trial patients was created and compared to the PFS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed or recurrent glioma of World Health Organization (WHO) grade II (astrocytoma, oligodendroglioma, and/or oligoastrocytoma) will be eligible for this protocol * Patients must have had surgical resection at University of California, Los Angeles (UCLA), for which a separate informed consent was signed for the collection of their tumor prior to surgery * After surgery, a pathological diagnosis of low-grade glioma (WHO grade II) will need to be established * Patients must be able to read and understand the informed consent document; patients must sign the informed consent indicating that they are aware of the investigational nature of this study. * Patients must have a Karnofsky performance status (KPS) rating of \>= 60 prior to initiating treatment; patients may be enrolled at a KPS of \< 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of \>= 60 by the initiation of treatment * Hemoglobin \>= 9 gm% * Absolute granulocyte count \>= 1,500 * Platelet count \>= 100,000/microliter (uL) * Serum glutamic pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 times institutional normals * Bilirubin =\< 1.5mg% * Blood urea nitrogen (BUN) or creatinine =\< 1.5 times institutional normals Exclusion Criteria: * Subjects with an active infection * Inability to obtain informed consent because of psychiatric or complicating medical problems * Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator * Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception * History of immunodeficiency (e.g., human immunodeficiency virus \[HIV\]) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy * Subjects with organ allografts * Inability or unwillingness to return for required visits and follow-up exams * Subjects who have an uncontrolled systemic malignancy that is not in remission
References
Publications (0)
Data not yet available
No reference posted for this study.