Vaccine Therapy in Treating Patients With Malignant Glioma

NCT ID: NCT00612001

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2012-10-31

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dendritic cell vaccine

Group Type: EXPERIMENTAL

glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

Intervention Type: BIOLOGICAL

Interventions

glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda M. Liau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Countries

United States

References

Prins RM, Wang X, Soto H, Young E, Lisiero DN, Fong B, Everson R, Yong WH, Lai A, Li G, Cloughesy TF, Liau LM. Comparison of glioma-associated antigen peptide-loaded versus autologous tumor lysate-loaded dendritic cell vaccination in malignant glioma patients. J Immunother. 2013 Feb;36(2):152-7. doi: 10.1097/CJI.0b013e3182811ae4.

Reference Type: DERIVED

PMID: 23377664 (View on PubMed)

Other Identifiers

R01CA112358

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCLA-06-01-052

Identifier Type: -

Identifier Source: secondary_id

CDR0000585166

Identifier Type: -

Identifier Source: org_study_id