Brain and Central Nervous System Tumors
Conditions
Keywords
adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma
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.
Interventions
BIOLOGICALaldesleukin
BIOLOGICALtherapeutic autologous lymphocytes
PROCEDUREadjuvant therapy
PROCEDUREconventional surgery
Sponsors
Hoag Memorial Hospital Presbyterian
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side effects and toxicity | — |
| Progression-free survival and overall survival | — |
Countries
United States
Outcome results
None listed