Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma
A Phase l Trial of Tumor Associated Antigen Pulsed Dendritic Cell Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of the Dendritic Cell Immunotherapy study for patients with glioblastoma and/or brainstem glioma is to determine whether in patients with malignant brain tumors, dendritic cells injected peripherally can reactivate the immune system against the brain tumor.
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 May 2007
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 18, 2007
CompletedFirst Posted
Study publicly available on registry
December 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedOctober 30, 2014
October 1, 2014
2.7 years
December 18, 2007
October 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate safety/toxicity of Dendritic cell vaccine, Monitor survival and time to progression and monitor the cellular immune responses.
1 year
Study Arms (1)
Vaccine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients must be HLA -A1 or HLA - A2 positive
- Both male and female of child bearing age must use medically accepted form of birth control
- Confirmed brain stem glioma and glioblastoma with MRI
- Presence of at least one of the antigens by immunohistochemistry
- Karnofsky performance of at least 60%
- On maintenance glucocorticoid therapy at no more 2 mg BID
- Hematologic and chemistry profiles within the parameters of the protocol
- Wash ou periods from previous therapies: 6 weeks from nitrosurea, 4 weeks from chemotherapy, 2 weeks after resolution of Grade 3 or 4 toxicity
- Able to sign IRB approved Informed consent
- Three adults will be treated prior to any study agent administration to subjects younger than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Related Publications (1)
Jouanneau E, Black KL, Veiga L, Cordner R, Goverdhana S, Zhai Y, Zhang XX, Panwar A, Mardiros A, Wang H, Gragg A, Zandian M, Irvin DK, Wheeler CJ. Intrinsically de-sialylated CD103(+) CD8 T cells mediate beneficial anti-glioma immune responses. Cancer Immunol Immunother. 2014 Sep;63(9):911-24. doi: 10.1007/s00262-014-1559-2. Epub 2014 Jun 4.
PMID: 24893855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Surasak Phuphanich, M.D.
Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 18, 2007
First Posted
December 19, 2007
Study Start
May 1, 2007
Primary Completion
January 1, 2010
Study Completion
April 1, 2012
Last Updated
October 30, 2014
Record last verified: 2014-10