Expired Study
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Los Angeles, California 90095


RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an 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 tumor lysate-pulsed dendritic cells in patients with malignant gliomas. - Determine survival, tumor progression, and cellular immune response in patients treated with this regimen. OUTLINE: This is a dose-escalation study. 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 and pulsed with autologous tumor lysate. Patients receive autologous tumor lysate-pulsed DC intradermally on days 0, 14, and 28 in the absence of unacceptable toxicity. Cohorts of 6-12 patients receive escalating doses of autologous tumor lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 2 years. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 9-18 months.


Eligibility Criteria: - Histologically confirmed diagnosis of one of the following malignant gliomas: - Anaplastic astrocytoma - Glioblastoma multiforme - Anaplastic oligodendroglioma - Malignant mixed oligoastrocytoma - WHO grade III or IV disease - Newly diagnosed disease - Bidimensionally measurable disease by contrast-enhancing MRI - Surgically accessible tumor for which resection is indicated - Previously treated with or plan to undergo treatment with conventional external beam radiotherapy - Age 18 and over - Performance status Karnofsky 60-100% - Life expectancy at least 8 weeks - Hemoglobin at least 10 g/dL - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - SGOT and SGPT no greater than 2 times normal - Alkaline phosphatase no greater than 2 times normal - Bilirubin no greater than 1.5 mg/dL - Hepatitis B negative - Hepatitis C negative - BUN no greater than 1.5 times normal - Creatinine no greater than 1.5 times normal - HIV negative - Syphilis serology negative - Afebrile - Negative pregnancy test - Fertile patients must use effective contraception - At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered. - At least 2 weeks since prior corticosteroids - At least 2 weeks since prior radiotherapy and recovered - More than 72 hours since prior systemic antibiotics 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 - pregnant or nursing - 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 - concurrent chemotherapy during and for 2 weeks after administration of study vaccine - concurrent corticosteroids prior organ allograft - antihistamine therapy within 5 days before or after administration of study vaccine - other concurrent investigational agents - concurrent adjuvant therapy during and for 2 weeks after administration of study vaccine



Primary Contact:

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

Backup Contact:


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: October 09, 2019

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