Cellular Immunotherapy Study for Brain Cancer (alloCTL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Jonsson Comprehensive Cancer Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01144247
First received: June 11, 2010
Last updated: May 27, 2014
Last verified: May 2014
  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: May 27, 2014
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
Central Nervous System Neoplasms
Meningeal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Vascular Tissue
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on October 21, 2014