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

Recurrent Adult Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635283
• Other study ID #: 11-002665
• Secondary ID: NCI-2012-00980
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2012
• Est. completion date: May 13, 2016

Study information

• Verified date: May 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 13, 2016
• Est. primary completion date: May 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• tumor lysate-pulsed autologous dendritic cell vaccine
Given ID

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate	a Kaplan-Meier curve of the PFS of our trial patients was created and compared to the PFS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.	Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.
Secondary	Overall Survival (OS)	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. a Kaplan-Meier curve of the OS of our trial patients was created and compared to the OS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.	The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.
Secondary	Anti-tumor Immune Responses	Tumor and peripheral blood samples were collected from each of the participants and analyzed for the following biomarkers: IDH1-specific antibodies CD8, PD-1, and PD-L1 content, and correlations among those three biomarkers Mutation analysis/sequencing	Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection.