Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Jonsson Comprehensive Cancer Center at UCLA

Linda M. Liau

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00068510
Information obtained from ClinicalTrials.gov on December 14, 2011

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