Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients
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.
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Jonsson Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
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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