Status:
COMPLETED
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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...
Detailed Description
OBJECTIVES: * Determine the feasibility, side effects, and toxicity associated with intracranial cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated killer cells in...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00331526
Start Date
February 1 1999
End Date
April 1 2012
Last Update
March 25 2013
Active Locations (1)
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1
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663