Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331526
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : March 25, 2013
Sponsor:
Information provided by (Responsible Party):
Hoag Memorial Hospital Presbyterian

Tracking Information
First Submitted Date  ICMJE May 30, 2006
First Posted Date  ICMJE May 31, 2006
Last Update Posted Date March 25, 2013
Study Start Date  ICMJE February 1999
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Side effects and toxicity
  • Progression-free survival and overall survival
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
Official Title  ICMJE Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
Brief Summary

RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells, including lymphokine-activated killer cells, to kill tumor cells. Giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells.

PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in treating patients with glioblastoma multiforme.

Detailed Description

OBJECTIVES:

  • Determine the feasibility, side effects, and toxicity associated with intracranial cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated killer cells in patients with glioblastoma multiforme.
  • Determine progression-free and overall survival of these patients.
  • Compare survival of these patients to that of contemporary and historical controls.

OUTLINE: Patients undergo therapeutic craniotomy.

Patients undergo leukapheresis to obtain lymphokine-activated killer (LAK) cells 3-7 days before therapeutic craniotomy OR 4-6 weeks after therapeutic craniotomy. Patients receive cellular adoptive immunotherapy comprising aldesleukin-stimulated LAK cells intracranially at the time of therapeutic craniotomy OR via an Ommaya reservoir (placed during craniotomy) no sooner than 4-6 weeks after therapeutic craniotomy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Biological: aldesleukin
  • Biological: therapeutic autologous lymphocytes
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
Study Arms  ICMJE Not Provided
Publications * Dillman RO, Duma CM, Ellis RA, Cornforth AN, Schiltz PM, Sharp SL, DePriest MC. Intralesional lymphokine-activated killer cells as adjuvant therapy for primary glioblastoma. J Immunother. 2009 Nov-Dec;32(9):914-9. doi: 10.1097/CJI.0b013e3181b2910f.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2013)
83
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Diagnosis of primary malignant glioblastoma multiforme (i.e., grade IV anaplastic astrocytoma)
  • Primary treatment (surgery, radiation, and/or chemotherapy) has been completed
  • Candidate for surgery and willing to undergo craniotomy
  • No progressive or recurrent disease
  • No residual disease that requires reoperation, additional gamma therapy, or other modality

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% (i.e., if symptomatic, bedridden < half of a waking day)
  • Life expectancy ≥ 2 months
  • Not pregnant
  • Negative pregnancy test
  • U.S. residents only
  • No hematopoietic, hepatic, renal, cardiovascular, or pulmonary laboratory values or other medical circumstances that would preclude surgery or aldesleukin therapy
  • No serious concurrent medical or psychiatric illness that would preclude informed consent or study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior anticancer therapy and recovered
  • Prior stereotactic or gamma knife radiosurgery allowed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00331526
Other Study ID Numbers  ICMJE CDR0000471241
HOAG-CBRG-98-09
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoag Memorial Hospital Presbyterian
Study Sponsor  ICMJE Hoag Memorial Hospital Presbyterian
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert O. Dillman, MD, FACP Hoag Memorial Hospital Presbyterian
PRS Account Hoag Memorial Hospital Presbyterian
Verification Date March 2013

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