Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
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ClinicalTrials.gov Identifier: NCT00331526 |
Recruitment Status :
Completed
First Posted : May 31, 2006
Last Update Posted : March 25, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Central Nervous System Tumors | Biological: aldesleukin Biological: therapeutic autologous lymphocytes Procedure: adjuvant therapy Procedure: conventional surgery | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes |
Study Start Date : | February 1999 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | April 2012 |

- Side effects and toxicity
- Progression-free survival and overall survival

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331526
United States, California | |
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian | |
Newport Beach, California, United States, 92663 |
Study Chair: | Robert O. Dillman, MD, FACP | Hoag Memorial Hospital Presbyterian |
Responsible Party: | Hoag Memorial Hospital Presbyterian |
ClinicalTrials.gov Identifier: | NCT00331526 |
Other Study ID Numbers: |
CDR0000471241 HOAG-CBRG-98-09 |
First Posted: | May 31, 2006 Key Record Dates |
Last Update Posted: | March 25, 2013 |
Last Verified: | March 2013 |
adult glioblastoma adult gliosarcoma adult giant cell glioblastoma |
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Aldesleukin Antineoplastic Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |