Vaccine Therapy in Treating Patients With Malignant Glioma
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas
2 other identifiers
interventional
28
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2003
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 10, 2003
CompletedFirst Posted
Study publicly available on registry
September 11, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedAugust 3, 2020
August 1, 2013
9.3 years
September 10, 2003
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicity
4 weeks
Secondary Outcomes (1)
Time to tumor progression, overall survival and cellular immune responses in brain tumor patients injected with tumor lysate pulsed dendritic cells
2 years
Study Arms (1)
autologous tumor lysate-pulsed DC
EXPERIMENTALInterventions
Eligibility Criteria
You may not qualify if:
- 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
- pregnant or nursing
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781, United States
Related Publications (2)
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.
PMID: 16061868RESULTPrins 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.
PMID: 23377664DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda M. Liau, MD, PhD
Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2003
First Posted
September 11, 2003
Study Start
June 1, 2003
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
August 3, 2020
Record last verified: 2013-08