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

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Adult Oligoastrocytoma

Adult Oligodendroglioma

Adult Diffuse Astrocytoma

Recurrent Adult Brain Tumor

Adult Mixed Glioma

Treatments

Biological: tumor lysate-pulsed autologous dendritic cell vaccine

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT01635283

NCI-2012-00980 (Registry Identifier)

11-002665

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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