Status:
COMPLETED
Vaccine Therapy in Treating Patients With Malignant Glioma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 effect...
Detailed 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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00612001
Start Date
May 1 2006
End Date
October 1 2012
Last Update
October 5 2015
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781