Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
NCT ID: NCT01635283
Last Updated: 2020-11-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
5 participants
INTERVENTIONAL
2012-01-10
2016-05-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
tumor lysate-pulsed autologous dendritic cell vaccine
Given ID
laboratory biomarker analysis
Correlative studies
Interventions
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tumor lysate-pulsed autologous dendritic cell vaccine
Given ID
laboratory biomarker analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Robert Prins
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2012-00980
Identifier Type: REGISTRY
Identifier Source: secondary_id
11-002665
Identifier Type: -
Identifier Source: org_study_id