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Cellular Immunotherapy Study for Brain Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01144247
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jonsson Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gliomas, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Glioma, Glioblastoma Multiforme, Malignant Meningioma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: alloreactive CTL arm

Interventions

Drug: - alloreactive CTL

cellular immunotherapy with alloCTL

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, Los Angeles, Los Angeles, California

Status

Address

University of California, Los Angeles

Los Angeles, California, 90095