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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


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
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