Cellular Immunotherapy Study for Brain Cancer (NCT01144247) | Clinical Trial Compass
CompletedPhase 1
Cellular Immunotherapy Study for Brain Cancer
United States10 participantsStarted 2010-07
Plain-language 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 determine if persons who receive aCTL's are more or less likely to survive their brain tumor than persons who had similar tumors in the past. Approximately 15 patients will be enrolled at UCLA.
Who can participate
Age range18 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of patients with adverse events as a measure of safety and tolerability