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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01635283
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE June 22, 2012
First Posted Date  ICMJE July 9, 2012
Results First Submitted Date  ICMJE May 6, 2019
Results First Posted Date  ICMJE November 4, 2020
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE January 10, 2012
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
Progression-free survival of low grade glioma patients treated with autologous dendritic cells pulsed with autologous tumor lysate [ Time Frame: Up to 5 years ]
Cox regression will be used.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
  • Overall Survival (OS) [ Time Frame: 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.
  • Anti-tumor Immune Responses [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
  • Overall survival [ Time Frame: 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. ]
  • Anti-tumor Immune Responses [ Time Frame: upto 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
Official Title  ICMJE A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma
Brief 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
Detailed Description

PRIMARY OBJECTIVES:

I. To determine the 5-year progression-free survival (PFS), using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate derived from surgical tissues in patients with low-grade gliomas.

SECONDARY OBJECTIVES:

I. To monitor overall survival (OS), and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells.

OUTLINE:

Patients receive tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 0, 14, and 28.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adult Diffuse Astrocytoma
  • Adult Mixed Glioma
  • Adult Oligodendroglioma
  • Recurrent Adult Brain Tumor
  • Adult Oligoastrocytoma
Intervention  ICMJE
  • Biological: tumor lysate-pulsed autologous dendritic cell vaccine
    Given ID
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (tumor lysate-pulsed autologous dendritic cells)
Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.
Interventions:
  • Biological: tumor lysate-pulsed autologous dendritic cell vaccine
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2020)
5
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2012)
18
Actual Study Completion Date  ICMJE May 13, 2016
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01635283
Other Study ID Numbers  ICMJE 11-002665
NCI-2012-00980 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Prins Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP