Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
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.
Status | Completed |
Enrollment | 83 |
Est. completion date | April 2012 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Hoag Cancer Center at Hoag Memorial Hospital Presbyterian | Newport Beach | California |
Lead Sponsor | Collaborator |
---|---|
Hoag Memorial Hospital Presbyterian |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Side effects and toxicity | Yes | ||
Primary | Progression-free survival and overall survival | No |
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