Vaccine Therapy in Treating Patients With Malignant Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00612001
First received: February 8, 2008
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Tumor progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 2006
Study Completion Date: October 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dendritic cell vaccine Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612001

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Linda M. Liau, MD, PhD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided by Jonsson Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00612001     History of Changes
Other Study ID Numbers: CDR0000585166, R01CA112358, UCLA-06-01-052
Study First Received: February 8, 2008
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
adult anaplastic astrocytoma
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic oligodendroglioma
recurrent adult brain tumor
adult mixed glioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014