Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00576537|
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : May 3, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Biological: Dendritic Cell Immunotherapy||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|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Dendritic Cell Immunotherapy
Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells.
Biological: Dendritic Cell Immunotherapy
Patients will receive four vaccines.
Other Name: Dendritic Cell vaccine
- Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells [ Time Frame: One year ]Cytotoxic T lymphocyte (CTL) precursor frequency
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.
- Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
- patients with atypical malignant brain tumor will be eligible.
- Patients must have a Karnofsky performance score of at least 60%
- patients may be maintained on glucocorticoid therapy at the lowest possible dose.
- Baseline hematologic studies and chemistry profiles must meet the criteria.
- Tumor specimen of adequate size to yield protein concentration in sufficient quantity.
- Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination.
- Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
- Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology.
- Patient must be capable of signing IRB approved Research Consent and Release of medical Records form.
- Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
- The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
- Patients with a known history of an autoimmune disorder.
- Inability to give informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Responsible Party:||John Yu, MD, Cedars-Sinai Medical Center|
|Other Study ID Numbers:||
|First Posted:||December 19, 2007 Key Record Dates|
|Last Update Posted:||May 3, 2019|
|Last Verified:||April 2019|
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