Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Malignant Glioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over NCI UCLA-0304053 NCT00068510

Objectives

1. Determine the dose-limiting toxicity and maximum tolerated dose of autologous tumor lysate-pulsed dendritic cells in patients with malignant gliomas.
2. Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 3-18 patients will be accrued for this study within 9-18 months.

Outcomes

Response
Time to tumor progression
Survival

Immune response

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.

Liau LM, Prins RM, Kiertscher SM, et al.: 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 11 (15): 5515-25, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Linda Liau, MD, PhD, Principal investigator		Ph: 310-267-2621; 888-798-0719

U.S.A.
California
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719

Registry Information
Official Title		Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas
Trial Start Date		2003-06-25
Registered in ClinicalTrials.gov		NCT00068510
Date Submitted to PDQ		2003-07-28
Information Last Verified		2008-04-20
NCI Grant/Contract Number		CA16042

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