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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: aldesleukin Biological: therapeutic autologous lymphocytes Procedure: adjuvant therapy Procedure: conventional surgery Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
Study Start Date : February 1999
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Side effects and toxicity
  2. Progression-free survival and overall survival

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331526


Locations
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United States, California
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Investigators
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Study Chair: Robert O. Dillman, MD, FACP Hoag Memorial Hospital Presbyterian
More Information
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Publications of Results:

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Responsible Party: Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT00331526    
Other Study ID Numbers: CDR0000471241
HOAG-CBRG-98-09
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: March 25, 2013
Last Verified: March 2013
Keywords provided by Hoag Memorial Hospital Presbyterian:
adult glioblastoma
adult gliosarcoma
adult giant cell glioblastoma
Additional relevant MeSH terms:
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Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents