Status:
COMPLETED
Dendritic Cell Vaccine for Patients With Brain Tumors
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Glioma
Anaplastic Astrocytoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already c...
Eligibility Criteria
Inclusion
- PATIENT ELIGIBILITY
- Inclusion Criteria
- Patients with newly diagnosed or recurrent glioma of WHO Grade III or IV {anaplastic astrocytoma (AA), anaplastic astro-oligodendroglioma (AO), or glioblastoma (GBM)} will be eligible for this protocol.
- Patients must have had surgical resection at UCLA (University of California, Los Angeles), for which a separate informed consent was signed for the collection of their tumor prior to surgery.
- After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
- Patients must be 18 years or older and able to read and understand the informed consent document. Patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
- Patients must have a Karnofsky performance status (KPS) rating of \> 60 prior to initiating treatment. Patients may be enrolled at a KPS of \< 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of \> 60 by the initiation of treatment.
- Exclusion Criteria
- Subjects with an active infection.
- Inability to obtain informed consent because of psychiatric or complicating medical problems.
- Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator.
- Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception.
- History of immunodeficiency (e.g., HIV) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy.
- Subjects with organ allografts.
- Inability or unwillingness to return for required visits and follow-up exams.
- Subjects who have an uncontrolled systemic malignancy that is not in remission.
Exclusion
Key Trial Info
Start Date :
October 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01204684
Start Date
October 8 2010
End Date
August 21 2024
Last Update
August 28 2024
Active Locations (1)
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1
University of Los Angeles, California
Los Angeles, California, United States, 90095