Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331526
• Other study ID #: CDR0000471241
• Secondary ID: HOAG-CBRG-98-09
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2006
• Last updated: March 22, 2013
• Start date: February 1999
• Est. completion date: April 2012

Study information

• Verified date: March 2013
• Source: Hoag Memorial Hospital Presbyterian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: April 2012
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Biological:
• aldesleukin

• therapeutic autologous lymphocytes

Procedure:
• adjuvant therapy

• conventional surgery

Locations

Country	Name	City	State
United States	Hoag Cancer Center at Hoag Memorial Hospital Presbyterian	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dillman RO, Duma CM, Ellis RA, Cornforth AN, Schiltz PM, Sharp SL, DePriest MC. Intralesional lymphokine-activated killer cells as adjuvant therapy for primary glioblastoma. J Immunother. 2009 Nov-Dec;32(9):914-9. doi: 10.1097/CJI.0b013e3181b2910f. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects and toxicity			Yes
Primary	Progression-free survival and overall survival			No