Vaccine Therapy in Treating Patients With Malignant Glioma

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

Brain and Central Nervous System Tumors

Treatments

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00612001

R01CA112358 (U.S. NIH Grant/Contract)

CDR0000585166

UCLA-06-01-052

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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