Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors
This study has been completed.
Sponsor:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
John Yu, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00576537
First received: December 18, 2007
Last updated: February 18, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Biological: Dendritic Cell Immunotherapy Biological: Dendritic Cell Vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cedars-Sinai Medical Center:
Primary Outcome Measures:
- Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells [ Time Frame: One year ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | March 2001 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Dendritic Cell Immunotherapy
Patients will receive four vaccines.
Other Name: Dendritic Cell vaccine
Biological: Dendritic Cell Vaccine
Four vaccines
Biological: Dendritic Cell Vaccine
Four vaccines will be given to patients
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576537
Locations
| United States, California | |
| Cedars Sinai Medical center | |
| Los Angeles, California, United States, 90048 | |
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
| Principal Investigator: | John Yu, M.D. | Cedars-Sinai Medical Center |
More Information
No publications provided
| Responsible Party: | John Yu, MD, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00576537 History of Changes |
| Other Study ID Numbers: | 3368 |
| Study First Received: | December 18, 2007 |
| Last Updated: | February 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cedars-Sinai Medical Center:
|
New/Recurrent Glioblastoma |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioblastoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 23, 2013