Status:
COMPLETED
Cellular Immunotherapy Study for Brain Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Gliomas
Anaplastic Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study to determine if treating recurrent malignant gliomas with another person's (donor) immune system cells known as aCTL cells, will be safe. This study will also try to...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- To participate in this clinical trial, patients must meet the following eligibility criteria:
- Subjects must have a histologically proven diagnosis of malignant glioma or meningioma and been treated with prior standard radiation and chemotherapy. There must be evidence of unequivocal progression by MRI.
- Tumor must be amenable to resection, and surgical resection must be clinically indicated.
- Age at least 18 years.
- Karnofsky performance scale score \>60.
- Adequate hematologic function: a) systemic white blood cell count greater than 2 x 103/mm3, b) platelet count greater than 100,000/mm3, c) hematocrit greater than 25%.
- Adequate renal function, with creatinine less than two times the upper limit.
- Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin \< 2x upper limit of normal.
- Patients must have an expected survival of at least three months.
- Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C.
- Patients must sign an informed consent.
- EXCLUSION CRITERIA
- Patients will be excluded from the trial if the patients:
- have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors.
- have prior tumor resections where the ventricles were extensively breached.
- are pregnant or breast-feeding women.
- are females of child-bearing potential unable or unwilling to practice adequate birth control methods.
- have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker).
- have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- have concurrent systemic infection.
- have any clinically significant, uncontrolled medical illness, as determined by the investigators.
- are unwilling or unable to comply with procedures required in this protocol.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01144247
Start Date
July 1 2010
End Date
July 1 2015
Last Update
May 27 2016
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095