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Vaccine Therapy in Treating Patients With Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00612001
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients
Study Start Date : May 2006
Actual Primary Completion Date : January 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: dendritic cell vaccine Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612001


Locations
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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Linda M. Liau, MD, PhD Jonsson Comprehensive Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00612001    
Other Study ID Numbers: CDR0000585166
R01CA112358 ( U.S. NIH Grant/Contract )
UCLA-06-01-052
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: August 2013
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:
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Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases