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A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma

Phase 2
18 Years
Open (Enrolling)
Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Tumor, Adult Oligoastrocytoma

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Trial Information

A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma


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


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


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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival of low grade glioma patients treated with autologous dendritic cells pulsed with autologous tumor lysate

Outcome Description:

Cox regression will be used.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Robert Prins

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • Adult Diffuse Astrocytoma
  • Adult Mixed Glioma
  • Adult Oligodendroglioma
  • Recurrent Adult Brain Tumor
  • Adult Oligoastrocytoma
  • Astrocytoma
  • Brain Neoplasms
  • Glioma
  • Oligodendroglioma



Jonsson Comprehensive Cancer Center Los Angeles, California  90095