Cellular Immunotherapy Study for Brain Cancer

Cellular Immunotherapy Study for Brain Cancer (alloCTL)
This study is currently recruiting participants.
Verified June 2010 by University of California, Los Angeles

First Received on June 11, 2010.  
Last Updated on May 22, 2012  
History of Changes
Sponsor: University of California, Los Angeles
Collaborators: National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01144247
  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
Drug: alloCTL 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: Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas

Resource links provided by NLM:

Further study details as provided by University of California, Los Angeles:

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: June 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Intervention Details:

    Drug: alloCTL

    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:

  1. Subjects must have a histologically proven diagnosis of malignant glioma 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 breached, or after resection for recurrent tumor in this trial the ventricles are broken.
  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.
  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
University of California, Los Angeles
  More Information

Additional Information:

Publications:

Responsible Party: Linda M. Liau, UCLA Division of Neurosurgery
ClinicalTrials.gov Identifier: NCT01144247    
History of Changes
Other Study ID Numbers: UCLA 07-09-008, R01CA125244
Study First Received: June 11, 2010
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

Recurrent Grade III or Grade IV Gliomas
anaplastic astrocytoma
anaplastic oligodendroglioma
anaplastic mixed glioma
glioblastoma multiforme
biotherapy

Additional relevant MeSH terms:

Astrocytoma
Glioblastoma
Glioma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 21, 2012

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