Vaccine Therapy in Treating Patients With Malignant Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612001
• Other study ID #: CDR0000585166
• Secondary ID: R01CA112358UCLA-
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2008
• Last updated: October 1, 2015
• Start date: May 2006
• Est. completion date: October 2012

Study information

• Verified date: August 2013
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Biological:
• glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides		3 months	Yes
Primary	Survival		1 year	No
Primary	Tumor progression		1 year	No