Anaplastic Astrocytoma, Anaplastic Mixed Glioma, Anaplastic Oligodendroglioma, Glioblastoma Multiforme, Gliomas, Malignant Meningioma
Conditions
Keywords
Recurrent Grade III or Grade IV Gliomas, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, glioblastoma multiforme, biotherapy, malignant meningioma
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 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.
Interventions
DRUGalloreactive CTL
cellular immunotherapy with alloCTL
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To participate in this clinical trial, patients must meet the following eligibility criteria: 1. 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. 2. Tumor must be amenable to resection, and surgical resection must be clinically indicated. 3. Age at least 18 years. 4. Karnofsky performance scale score \>60. 5. 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%. 6. Adequate renal function, with creatinine less than two times the upper limit. 7. Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin \< 2x upper limit of normal. 8. Patients must have an expected survival of at least three months. 9. Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C. 10. Patients must sign an informed consent.
Exclusion criteria
Patients will be excluded from the trial if the patients: 1. have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors. 2. have prior tumor resections where the ventricles were extensively breached. 3. are pregnant or breast-feeding women. 4. are females of child-bearing potential unable or unwilling to practice adequate birth control methods. 5. have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker). 6. have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. 7. have concurrent systemic infection. 8. have any clinically significant, uncontrolled medical illness, as determined by the investigators. 9. are unwilling or unable to comply with procedures required in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events as a measure of safety and tolerability | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | 3 years |
Countries
United States
Outcome results
None listed