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| ID | Type | Description | Link |
|---|---|---|---|
| UCLA-0304053 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma.
OBJECTIVES:
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 6-12 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 2 years.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 9-18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous tumor lysate-pulsed DC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic autologous dendritic cells | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to tumor progression, overall survival and cellular immune responses in brain tumor patients injected with tumor lysate pulsed dendritic cells | 2 years |
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Eligibility Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda M. Liau, MD, PhD | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16061868 | Result | Liau LM, Prins RM, Kiertscher SM, Odesa SK, Kremen TJ, Giovannone AJ, Lin JW, Chute DJ, Mischel PS, Cloughesy TF, Roth MD. Dendritic cell vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the local central nervous system tumor microenvironment. Clin Cancer Res. 2005 Aug 1;11(15):5515-25. doi: 10.1158/1078-0432.CCR-05-0464. | |
| 23377664 |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D001932 | Brain Neoplasms |
| D018316 | Gliosarcoma |
| D009837 | Oligodendroglioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| Derived |
| Prins RM, Wang X, Soto H, Young E, Lisiero DN, Fong B, Everson R, Yong WH, Lai A, Li G, Cloughesy TF, Liau LM. Comparison of glioma-associated antigen peptide-loaded versus autologous tumor lysate-loaded dendritic cell vaccination in malignant glioma patients. J Immunother. 2013 Feb;36(2):152-7. doi: 10.1097/CJI.0b013e3182811ae4. |
| D005910 |
| Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |