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

June 11, 2010
May 27, 2014
July 2010
July 2015   (final data collection date for primary outcome measure)
Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01144247 on ClinicalTrials.gov Archive Site
Maximum tolerated dose [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cellular Immunotherapy Study for Brain Cancer
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gliomas
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Mixed Glioma
  • Glioblastoma Multiforme
  • Malignant Meningioma
Drug: alloreactive CTL
cellular immunotherapy with alloCTL
Experimental: alloreactive CTL arm
Intervention: Drug: alloreactive CTL

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United States
 
NCT01144247
UCLA 07-09-008, R01CA125244
Yes
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Not Provided
Jonsson Comprehensive Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP