View Clinical Trial (Medical Research Study)
A Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas or Meningiomas
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Los Angeles |
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California |
| Zip Code: |
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90095 |
| Conditions: |
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Gliomas - Anaplastic Astrocytoma - Anaplastic Oligodendroglioma - Anaplastic Mixed Glioma - Glioblastoma Multiforme - Malignant Meningioma |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01144247 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Los Angeles, California 90095
United States
Linda Liau, M.D., Ph.D.
Phone: 310-267-2621
Email: LLiau@mednet.ucla.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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