Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors
|ClinicalTrials.gov Identifier: NCT00576537|
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : February 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Biological: Dendritic Cell Immunotherapy Biological: Dendritic Cell Vaccine||Phase 2|
To become eligible for therapy the following criteria must be fulfilled:
- No age or gender limit
- Patients with atypical malignant brain tumors.
- Must have a Karnofsky performance of at least 60%
- Hematologic studies and chemistry profiles will be within the parameters of the protocol
- Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine.
- Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System|
|Study Start Date :||March 2001|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
Biological: Dendritic Cell Immunotherapy
Patients will receive four vaccines.
Other Name: Dendritic Cell vaccineBiological: Dendritic Cell Vaccine
Four vaccinesBiological: Dendritic Cell Vaccine
Four vaccines will be given to patients
- Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells [ Time Frame: One year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576537
|United States, California|
|Cedars Sinai Medical center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||John Yu, M.D.||Cedars-Sinai Medical Center|