- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01144247
Cellular Immunotherapy Study for Brain Cancer (alloCTL)
May 26, 2016 updated by: Jonsson Comprehensive Cancer Center
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
INCLUSION CRITERIA
To participate in this clinical trial, patients must meet the following eligibility 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.
- Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C.
- Patients must sign an informed consent.
EXCLUSION CRITERIA
Patients will be excluded from the trial if the patients:
- 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.
- have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker).
- have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- have concurrent systemic infection.
- have any clinically significant, uncontrolled medical illness, as determined by the investigators.
- are unwilling or unable to comply with procedures required in this protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: alloreactive CTL arm
|
cellular immunotherapy with alloCTL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events as a measure of safety and tolerability
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hickey MJ, Malone CC, Erickson KL, Jadus MR, Prins RM, Liau LM, Kruse CA. Cellular and vaccine therapeutic approaches for gliomas. J Transl Med. 2010 Oct 14;8:100. doi: 10.1186/1479-5876-8-100.
- Hickey MJ, Malone CC, Erickson KE, Gomez GG, Young EL, Liau LM, Prins RM, Kruse CA. Implementing preclinical study findings to protocol design: translational studies with alloreactive CTL for gliomas. Am J Transl Res. 2012;4(1):114-26. Epub 2012 Jan 10.
- Kruse CA, Cepeda L, Owens B, Johnson SD, Stears J, Lillehei KO. Treatment of recurrent glioma with intracavitary alloreactive cytotoxic T lymphocytes and interleukin-2. Cancer Immunol Immunother. 1997 Oct;45(2):77-87. doi: 10.1007/s002620050405.
- Kruse, C.A., Rubinstein, D. (2001) Cytotoxic T Lymphocytes Reactive to Patient Major Histocompatibility Proteins for Therapy of Recurrent Primary Brain Tumors, in Brain Tumor Immunotherapy, eds. L.M. Liau, D.P. Becker, T.F. Cloughsey, and D. Bigner, Humana Press, pp. 149-170
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
June 11, 2010
First Submitted That Met QC Criteria
June 14, 2010
First Posted (Estimate)
June 15, 2010
Study Record Updates
Last Update Posted (Estimate)
May 27, 2016
Last Update Submitted That Met QC Criteria
May 26, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Glioblastoma
- Glioma
- Astrocytoma
- Oligodendroglioma
- Meningioma
Other Study ID Numbers
- UCLA 07-09-008
- R01CA125244 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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