Vaccine Therapy in Treating Patients With Malignant Glioma

Completed · Phase 1

Conditions studied: Brain and Central Nervous System Tumors

In brief

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.

Key facts

Study ID

NCT00612001

Run by

Jonsson Comprehensive Cancer Center

People needed

8

Starts

2006-05-01

Expected to finish

2012-10-01

Last updated by the study team

2015-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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