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NCT01635283

Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma

Completed Phase 2 Results posted Last updated 4 November 2020
What this trial tests

Phase 2 trial testing tumor lysate-pulsed autologous dendritic cell vaccine in Adult Diffuse Astrocytoma in 5 participants. Completed in 13 May 2016.

Timeline
10 January 2012
Primary endpoint
13 May 2016
13 May 2016

Quick facts

Lead sponsorJonsson Comprehensive Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date10 January 2012
Primary completion13 May 2016
Estimated completion13 May 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Adult Diffuse Astrocytoma or Adult Mixed Glioma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate Primary · Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.

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.

0-6 months
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)0
7-12 months
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)1
13-18 months
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)1
19-24 months
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)1
25-30 months
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)0
>30 months
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)2
Overall Survival (OS) Secondary · The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.

From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months. a Kaplan-Meier curve of the OS of our trial patients was created and compared to the OS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.

Deceased
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)0
Alive
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)5
Lost to Follow-Up
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)0
Withdrawal by Subject
GroupValue95% CI
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)0
Anti-tumor Immune Responses Secondary · Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection.

Tumor and peripheral blood samples were collected from each of the participants and analyzed for the following biomarkers: IDH1-specific antibodies CD8, PD-1, and PD-L1 content, and correlations among those three biomarkers Mutation analysis/sequencing

GroupValue95% CI
%CD8+/Field1.26± 1.03
%PD-1+/Field1.35± 1.04
%PD-L1+/Field6.76± 3.30

Adverse events — posted to ClinicalTrials.gov

Time frame: The timeframe for adverse event reporting was from the day of the first vaccine treatment until the patient discontinued the study for any reason, up to 44 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Serious: 0/5 (0%)
Deaths: 0/5
Other adverse events (14 terms — click to expand)

ReactionSystemTreatment (Tumor Lysate-pu…
SeizureNervous system disorders
HeadacheGeneral disorders
FatigueGeneral disorders
AnemiaBlood and lymphatic system disorders
DysphasiaNervous system disorders
Visual DistortionsNervous system disorders
cognitive slownessNervous system disorders
FracturesMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
Squamous cell carcinomasNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary Tract InfectionInfections and infestations
Upper respritory infectionInfections and infestations
NauseaGastrointestinal disorders
RhinorrheaGeneral disorders

Data from ClinicalTrials.gov NCT01635283 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Personalized Dendritic Cell Vaccines-Recent Breakthroughs and Encouraging Clinical Results.
    Mastelic-Gavillet B, Balint K, Boudousquie C, Gannon PO, et al · · 2019 · cited 145× · PMID 31031762 · DOI 10.3389/fimmu.2019.00766
  2. Immunotherapy for primary brain tumors: no longer a matter of privilege.
    Fecci PE, Heimberger AB, Sampson JH. · · 2014 · cited 83× · PMID 25398845 · DOI 10.1158/1078-0432.ccr-14-0832
  3. Neoantigen Vaccines; Clinical Trials, Classes, Indications, Adjuvants and Combinatorial Treatments.
    Niemi JVL, Sokolov AV, Schiöth HB. · · 2022 · cited 42× · PMID 36291947 · DOI 10.3390/cancers14205163
  4. Clinical implication of cellular vaccine in glioma: current advances and future prospects.
    Yan Y, Zeng S, Gong Z, Xu Z. · · 2020 · cited 42× · PMID 33228738 · DOI 10.1186/s13046-020-01778-6
  5. The immunology of low-grade gliomas.
    Haddad AF, Young JS, Oh JY, Okada H, et al · · 2022 · cited 35× · PMID 35104791 · DOI 10.3171/2021.11.focus21587
  6. Immunotherapy of Malignant Tumors in the Brain: How Different from Other Sites?
    Dutoit V, Migliorini D, Dietrich PY, Walker PR. · · 2016 · cited 35× · PMID 28003994 · DOI 10.3389/fonc.2016.00256
  7. Cellular immunotherapy for malignant gliomas.
    Lin Y, Okada H. · · 2016 · cited 34× · PMID 27434205 · DOI 10.1080/14712598.2016.1214266
  8. Tumor-derived systems as novel biomedical tools-turning the enemy into an ally.
    Desai N, Katare P, Makwana V, Salave S, et al · · 2023 · cited 20× · PMID 37946275 · DOI 10.1186/s40824-023-00445-z

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