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Vaccine Therapy in Treating Patients With Malignant Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00612001
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Jonsson Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Linda M. Liau, MD, PhD
Principal Investigator Affiliation Jonsson Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Arms & Interventions

Arms

Experimental: dendritic cell vaccine

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Address

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781

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