Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme - Full Text View

Sponsored by:	Hoag Memorial Hospital Presbyterian
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00331526

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: aldesleukin Drug: therapeutic autologous lymphocytes Procedure: adjuvant therapy Procedure: conventional surgery	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Aldesleukin Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Side effects and toxicity [ Designated as safety issue: Yes ]
Progression-free survival and overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 1999
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331526

Locations

United States, California
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663

Sponsors and Collaborators

Hoag Memorial Hospital Presbyterian

Investigators

Study Chair:

Robert O. Dillman, MD, FACP

Hoag Memorial Hospital Presbyterian

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Hoag Cancer Center at Hoag Memorial Hospital Presbyterian ( Robert O. Dillman )
Study ID Numbers:	CDR0000471241, HOAG-CBRG-98-09
Study First Received:	May 30, 2006
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00331526
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult gliosarcoma
adult giant cell glioblastoma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Central Nervous System Neoplasms
Neuroectodermal Tumors
Aldesleukin
Glioblastoma multiforme
Interleukin-2

Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Antiviral Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Therapeutic Uses
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 15, 2009