Expired Study
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Los Angeles, California 90095


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.


Study summary:

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.


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


NCT ID:

NCT00612001


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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