Phase 2
N=5
Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
Adult Diffuse Astrocytoma · Adult Mixed Glioma · Adult Oligodendroglioma · Recurrent Adult Brain Tumor · Adult Oligoastrocytoma
Bottom Line
View on ClinicalTrials.gov: NCT01635283 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate — 0; 1; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tumor lysate-pulsed autologous dendritic cell vaccine (Biological); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jonsson Comprehensive Cancer Center
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate |
0; 1; 1; 1; 0; 2 | — |
| SECONDARY Overall Survival (OS) |
0; 5; 0; 0 | — |
| SECONDARY Anti-tumor Immune Responses |
1.26; 1.35; 6.76 | — |
Summary
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
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01635283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.