Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Biological: aldesleukin
* Biological: therapeutic autologous lymphocytes
* Procedure: adjuvant therapy
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: therapeutic autologous lymphocytes|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects and toxicity |  |  | 
| Progression-free survival and overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma