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

Completed · Phase 2

Conditions studied: Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Tumor, Adult Oligoastrocytoma

In brief

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

Key facts

Study ID

NCT01635283

Run by

Jonsson Comprehensive Cancer Center

People needed

5

Starts

2012-01-10

Expected to finish

2016-05-13

Last updated by the study team

2020-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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