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Vaccine Therapy in Treating Patients With Malignant Glioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00612001
  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
Drug: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Glioma-Associated Antigen (GAA) Peptide-Pulsed Dendritic Cell Vaccination in Malignant Glioma Patients

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 18
Study Start Date: December 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Hepatitis B negative
  • Hepatitis C negative
  • HIV negative
  • Syphilis serology negative
  • Afebrile
  • No active infection
  • No immunodeficiency
  • No 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
  • No allergy to study agents
  • No underlying condition that would contraindicate study therapy
  • No concurrent severe or unstable medical condition that would preclude giving informed consent
  • No psychiatric condition that would preclude study participation or giving informed consent
  • No 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 CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • At least 2 weeks since prior and no concurrent corticosteroids
  • At least 2 weeks since prior radiotherapy and recovered
  • More than 72 hours since prior systemic antibiotics
  • No prior organ allograft
  • No antihistamine therapy within 5 days before or after administration of study vaccine
  • No chemotherapy during and for 4 weeks after administration of study vaccine
  • No adjuvant therapy during and for 4 weeks after administration of study vaccine
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612001

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a     888-798-0719        
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Linda M. Liau, MD, PhD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000585166, UCLA-06-01-052
Study First Received: February 8, 2008
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00612001  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult anaplastic astrocytoma
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic oligodendroglioma
recurrent adult brain tumor
adult mixed glioma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Central Nervous System Neoplasms
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 13, 2009