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

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ClinicalTrials.gov Identifier: NCT01635283
Recruitment Status : Active, not recruiting
First Posted : July 9, 2012
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Adult Diffuse Astrocytoma Adult Mixed Glioma Adult Oligodendroglioma Recurrent Adult Brain Tumor Adult Oligoastrocytoma Biological: tumor lysate-pulsed autologous dendritic cell vaccine Other: laboratory biomarker analysis Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma
Study Start Date : January 2012
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: tumor lysate-pulsed autologous dendritic cell vaccine
Given ID

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
  2. Anti-tumor immune responses [ Time Frame: upto 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 >= 100K
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635283


Locations
United States, California
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Robert Prins Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01635283     History of Changes
Other Study ID Numbers: 11-002665
NCI-2012-00980 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Glioma
Astrocytoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vaccines
Immunologic Factors
Physiological Effects of Drugs