Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors
April 30, 2019 updated by: John Yu, Cedars-Sinai Medical Center
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
This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Dendritic Cell Immunotherapy
Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells.
|
Patients will receive four vaccines.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells
Time Frame: One year
|
Cytotoxic T lymphocyte (CTL) precursor frequency
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2001
Primary Completion (ACTUAL)
October 1, 2011
Study Completion (ACTUAL)
October 1, 2011
Study Registration Dates
First Submitted
December 18, 2007
First Submitted That Met QC Criteria
December 18, 2007
First Posted (ESTIMATE)
December 19, 2007
Study Record Updates
Last Update Posted (ACTUAL)
May 3, 2019
Last Update Submitted That Met QC Criteria
April 30, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3368
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.