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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Malignant Glioma  Vaccine Therapy in Treating Patients With Malignant Glioma
Vaccine Therapy in Treating Patients With Malignant Glioma
For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma,recurrent adult brain tumor
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have malignantglioma.
Details: OBJECTIVES: - Determine the dose-limiting toxicity and maximum tolerated dose of autologous tumor lysate-pulsed dendritic cells in patients with malignant gliomas. - Determine survival, tumor progression, and cellular immune response in patients treated with this regimen. OUTLINE: This is a dose-escalation study. 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 and pulsed with autologous tumor lysate. Patients receive autologous tumor lysate-pulsed DC intradermally on days 0, 14, and 28 in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of autologous tumor lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 1 year. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 9-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of one of the following malignant gliomas: - Anaplastic astrocytoma - Glioblastoma multiforme - 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 plan to undergo treatment with conventional external beam radiotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - At least 8 weeks Hematopoietic - Hemoglobin at least 10 g/dL - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - SGOT and SGPT no greater than 2 times normal - Alkaline phosphatase no greater than 2 times normal - Bilirubin no greater than 1.5 mg/dL - Hepatitis B negative - Hepatitis C negative Renal - BUN no greater than 1.5 times normal OR - Creatinine no greater than 1.5 times normal Immunologic - HIV negative - Syphilis serology negative - Afebrile - No active infection - No immunodeficiency - No 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 - No allergy to study agents Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No underlying condition that would contraindicate study therapy - No concurrent severe or unstable medical condition that would preclude giving informed consent - No psychiatric condition that would preclude study participation or giving informed consent - No 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 CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent chemotherapy during and for 4 weeks after administration of study vaccine Endocrine therapy - At least 2 weeks since prior corticosteroids - No concurrent corticosteroids Radiotherapy - See Disease Characteristics - At least 2 weeks since prior radiotherapy and recovered Surgery - See Disease Characteristics - No prior organ allograft Other - More than 72 hours since prior systemic antibiotics - No antihistamine therapy within 5 days before or after administration of study vaccine - No other concurrent investigational agents - No concurrent adjuvant therapy during and for 4 weeks after administration of study vaccine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LindaLiau, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-6901
United States
Recruiting Linda Liau 310-267-2621
Additional Information:
Study ID Numbers: CDR0000327711; UCLA-0304053
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068510
Other Adult Glioblastoma Multiforme Studies:
1. Brachytherapy in Treating Patients With Recurrent Malignant Glioma
2. Erlotinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
3. ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse
4. Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
5. Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other California Clinical Trials
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Vaccine Therapy in Treating Patients With Malignant Glioma
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