Vaccine Therapy in Treating Patients With Malignant Glioma

October 1, 2015 updated by: Jonsson Comprehensive Cancer Center

Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients

RATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides in patients with malignant gliomas.
  • Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.

OUTLINE: Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC). Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF) and interleukin-4 (IL-4), matured with a cytokine cocktail, and pulsed with synthetic glioma-associated antigen (GAA) peptides. Cohorts of patients receive escalating doses of GAA peptide-pulsed autologous dendritic cell vaccine until the maximum tolerated dose is determined.

After completion of study treatment, patients are followed every 2 months for 1 year.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of 1 of the following malignant gliomas:
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Oligodendroglioma
  • Oligoastrocytoma
  • WHO grade III or IV disease
  • Newly diagnosed or recurrent disease
  • Bidimensionally measurable disease by contrast-enhancing MRI
  • Surgically accessible tumor for which resection is indicated
  • Previously treated with or planning to undergo treatment with conventional external beam radiotherapy
  • HLA-A*201 positive
  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 8 weeks
  • Hemoglobin ≥ 10 g/dL
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • SGOT and SGPT ≤ 2 times normal
  • Alkaline phosphatase ≤ 2 times normal
  • Bilirubin ≤ 1.5 mg/dL
  • BUN ≤ 1.5 times normal OR creatinine ≤ 1.5 times normal
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Hepatitis B negative
  • Hepatitis C negative
  • HIV negative
  • Syphilis serology negative
  • Afebrile

Exclusion Criteria:

  • active infection
  • immunodeficiency
  • autoimmune disease that may be exacerbated by immunotherapy, including any of the following:
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Vasculitis
  • Polymyositis-dermatomyositis
  • Scleroderma
  • Multiple sclerosis
  • Juvenile-onset insulin-dependent diabetes
  • allergy to study agents
  • underlying condition that would contraindicate study therapy
  • concurrent severe or unstable medical condition that would preclude giving informed consent
  • psychiatric condition that would preclude study participation or giving informed consent
  • other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix
  • prior chemotherapy (6 weeks for nitrosoureas) within last 4 weeks of starting treatment
  • concurrent corticosteroids within 2 weeks prior to treatment
  • radiotherapy within 2 weeks prior to treatment
  • systemic antibiotics within 72 hours prior to treatment
  • prior organ allograft
  • antihistamine therapy within 5 days before or after administration of study vaccine
  • chemotherapy during and for 4 weeks after administration of study vaccine
  • adjuvant therapy during and for 4 weeks after administration of study vaccine
  • other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dendritic cell vaccine
Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 1 year
1 year
Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides
Time Frame: 3 months
3 months
Tumor progression
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Linda M. Liau, MD, PhD, Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000585166
  • R01CA112358 (U.S. NIH Grant/Contract)
  • UCLA-06-01-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain and Central Nervous System Tumors

Clinical Trials on glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe