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

NCT01635283 | Completed Phase 2 Results DMC

• 2 other identifiers: 11-002665NCI-2012-00980
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival (OS)

  The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.

• Anti-tumor Immune Responses

  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.

Study Arms (1)

Treatment (tumor lysate-pulsed autologous dendritic cells)

EXPERIMENTAL

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

Biological: tumor lysate-pulsed autologous dendritic cell vaccine; Other: laboratory biomarker analysis

Interventions

tumor lysate-pulsed autologous dendritic cell vaccine BIOLOGICAL

Given ID

Treatment (tumor lysate-pulsed autologous dendritic cells)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (tumor lysate-pulsed autologous dendritic cells)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Astrocytoma; Glioma; Oligodendroglioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Robert Prins
• Organization: Jonsson Comprehensieve Cancer Center

rprins@mednet.ucla.edu

310-825-7647

Study Officials

• Robert Prins

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: July 9, 2012
• Study Start: January 10, 2012
• Primary Completion: May 13, 2016
• Study Completion: May 13, 2016
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2016-05

Locations

US (1)