Vaccine Therapy in Treating Patients With Malignant Glioma - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00068510

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Biological: therapeutic autologous dendritic cells	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

To determine Dose Limiting Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To monitor time to tumor progression, overall survival and cellular immune responses in brain tumor patients injected with tumor lysate pulsed dendritic cells [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	June 2003
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068510

Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

University of California, Los Angeles

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Linda M. Liau, MD, PhD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

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

Publications:

Liau LM, Prins RM, Kiertscher SM, Odesa SK, Kremen TJ, Giovannone AJ, Lin JW, Chute DJ, Mischel PS, Cloughesy TF, Roth MD. Dendritic cell vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the local central nervous system tumor microenvironment. Clin Cancer Res. 2005 Aug 1;11(15):5515-25.

Responsible Party:	Linda Liau, UCLA
ClinicalTrials.gov Identifier:	NCT00068510 History of Changes
Other Study ID Numbers:	CDR0000327711, P30CA016042, UCLA-0304053
Study First Received:	September 10, 2003
Last Updated:	February 18, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

adult glioblastoma
adult anaplastic astrocytoma
adult brain tumor

adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic oligodendroglioma

Additional relevant MeSH terms:

Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms by Site
Neoplasms
Nervous System Diseases

Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on February 09, 2012