Cellular Immunotherapy Study for Brain Cancer (alloCTL)
This study is currently recruiting participants.
Verified February 2013 by Jonsson Comprehensive Cancer Center
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborators:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01144247
First received: June 11, 2010
Last updated: February 11, 2013
Last verified: February 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gliomas Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Mixed Glioma Glioblastoma Multiforme Malignant Meningioma |
Drug: alloreactive CTL |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Maximum tolerated dose [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 15 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: alloreactive CTL arm |
Drug: alloreactive CTL
cellular immunotherapy with alloCTL
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144247
Locations
| United States, California | |
| University of California, Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Linda Liau, M.D., Ph.D. 310-267-2621 LLiau@mednet.ucla.edu | |
| Contact: Emma Young, R.N. 310-267-2621 elyoung@mednet.ucla.edu | |
| Sub-Investigator: Carol A. Kruse, Ph.D. | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
More Information
Additional Information:
Related Info 
Publications:
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01144247 History of Changes |
| Other Study ID Numbers: | UCLA 07-09-008, R01CA125244 |
| Study First Received: | June 11, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
Recurrent Grade III or Grade IV Gliomas anaplastic astrocytoma anaplastic oligodendroglioma anaplastic mixed glioma |
glioblastoma multiforme biotherapy malignant meningioma |
Additional relevant MeSH terms:
|
Oligodendroglioma Astrocytoma Glioblastoma Glioma Meningioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Meningeal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013