Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
NCT ID: NCT00331526
Last Updated: 2013-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
1999-02-28
2012-04-30
Brief Summary
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PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in treating patients with glioblastoma multiforme.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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aldesleukin
therapeutic autologous lymphocytes
adjuvant therapy
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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Hoag Memorial Hospital Presbyterian
OTHER
Responsible Party
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Principal Investigators
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Robert O. Dillman, MD, FACP
Role: STUDY_CHAIR
Hoag Memorial Hospital Presbyterian
Locations
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Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Countries
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References
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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.
Other Identifiers
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HOAG-CBRG-98-09
Identifier Type: -
Identifier Source: secondary_id
CDR0000471241
Identifier Type: -
Identifier Source: org_study_id
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