Vaccine Therapy in Treating Patients With Malignant Glioma

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

• Registration Number: NCT00612001
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

RATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build an effective 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.

Detailed Description

OBJECTIVES:

* Determine the dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides in patients with malignant gliomas.

* Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.

OUTLINE: 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 (IL-4), matured with a cytokine cocktail, and pulsed with synthetic glioma-associated antigen (GAA) peptides. Cohorts of patients receive escalating doses of GAA peptide-pulsed autologous dendritic cell vaccine until the maximum tolerated dose is determined.

After completion of study treatment, patients are followed every 2 months for 1 year.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-11
• Primary Completion: 2011-01
• Study Completion: 2012-10
• Status Verified: 2013-08
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Histologically confirmed diagnosis of 1 of the following malignant gliomas:
• Anaplastic astrocytoma
• Glioblastoma multiforme
• Oligodendroglioma
• Oligoastrocytoma
• WHO grade III or IV disease
• Newly diagnosed or recurrent disease
• Bidimensionally measurable disease by contrast-enhancing MRI
• Surgically accessible tumor for which resection is indicated
• Previously treated with or planning to undergo treatment with conventional external beam radiotherapy
• HLA-A*201 positive
• Karnofsky performance status 60-100%
• Life expectancy ≥ 8 weeks
• Hemoglobin ≥ 10 g/dL
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• SGOT and SGPT ≤ 2 times normal
• Alkaline phosphatase ≤ 2 times normal
• Bilirubin ≤ 1.5 mg/dL
• BUN ≤ 1.5 times normal OR creatinine ≤ 1.5 times normal
• Negative pregnancy test
• Fertile patients must use effective contraception
• Hepatitis B negative
• Hepatitis C negative
• HIV negative
• Syphilis serology negative
• Afebrile

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
• 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
• prior chemotherapy (6 weeks for nitrosoureas) within last 4 weeks of starting treatment
• concurrent corticosteroids within 2 weeks prior to treatment
• radiotherapy within 2 weeks prior to treatment
• systemic antibiotics within 72 hours prior to treatment
• prior organ allograft
• antihistamine therapy within 5 days before or after administration of study vaccine
• chemotherapy during and for 4 weeks after administration of study vaccine
• adjuvant therapy during and for 4 weeks after administration of study vaccine
• other concurrent investigational agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dendritic cell vaccine	glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine	-

Primary Outcome Measures

Name	Time	Method
Tumor progression	1 year
Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides	3 months
Survival	1 year

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States