Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

Hoag Health Network

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Procedure: adjuvant therapy; Biological: therapeutic autologous lymphocytes; Biological: aldesleukin; Procedure: conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00331526

HOAG-CBRG-98-09

CDR0000471241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)