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

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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:	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 National Cancer Institute (NCI):

Primary Outcome Measures:

Response [ Designated as safety issue: No ]
Time to tumor progression [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immune response [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	June 2003

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

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

At least 8 weeks

Hematopoietic

Hemoglobin at least 10 g/dL
Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

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

Renal

BUN no greater than 1.5 times normal OR
Creatinine no greater than 1.5 times normal

Immunologic

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

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
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:

Biologic therapy

Not specified

Chemotherapy

At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
No concurrent chemotherapy during and for 2 weeks after administration of study vaccine

Endocrine therapy

At least 2 weeks since prior corticosteroids
No concurrent corticosteroids

Radiotherapy

See Disease Characteristics
At least 2 weeks since prior radiotherapy and recovered

Surgery

See Disease Characteristics
No prior organ allograft

Other

More than 72 hours since prior systemic antibiotics
No antihistamine therapy within 5 days before or after administration of study vaccine
No other concurrent investigational agents
No 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	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

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.

Study ID Numbers:	CDR0000327711, UCLA-0304053
Study First Received:	September 10, 2003
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00068510 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult anaplastic astrocytoma
adult brain tumor

adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic oligodendroglioma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue

Nervous System Diseases
Glioma
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009