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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides

Safety Issue:

Yes

Principal Investigator

Linda M. Liau, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000585166

NCT ID:

NCT00612001

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult anaplastic oligodendroglioma
  • recurrent adult brain tumor
  • adult mixed glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781