Brain and Central Nervous System Tumors
Conditions
Keywords
adult anaplastic astrocytoma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult mixed glioma
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 effects and best dose of vaccine therapy in treating patients with malignant glioma.
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 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.
Interventions
BIOLOGICALglioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
Sponsors
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides | 3 months |
| Survival | 1 year |
| Tumor progression | 1 year |
Countries
United States
Outcome results
None listed