Cellular Immunotherapy Study for Brain Cancer (alloCTL)

Jonsson Comprehensive Cancer Center

Status and phase: Completed; Phase 1

Conditions: Glioblastoma Multiforme; Malignant Meningioma; Gliomas; Anaplastic Mixed Glioma; Anaplastic Oligodendroglioma; Anaplastic Astrocytoma

Treatments: Drug: alloreactive CTL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01144247

R01CA125244 (U.S. NIH Grant/Contract)

UCLA 07-09-008

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

alloreactive CTL arm

Experimental group

Treatment:

Drug: alloreactive CTL