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Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
therapeutic autologous lymphocytes
adjuvant therapy
conventional surgery
Sponsored by
Hoag Memorial Hospital Presbyterian
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Outcomes

Primary Outcome Measures

Side effects and toxicity
Progression-free survival and overall survival

Secondary Outcome Measures

Full Information

First Posted
May 30, 2006
Last Updated
March 22, 2013
Sponsor
Hoag Memorial Hospital Presbyterian
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1. Study Identification

Unique Protocol Identification Number
NCT00331526
Brief Title
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
Official Title
Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoag Memorial Hospital Presbyterian

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous lymphocytes
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Side effects and toxicity
Title
Progression-free survival and overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O. Dillman, MD, FACP
Organizational Affiliation
Hoag Memorial Hospital Presbyterian
Official's Role
Study Chair
Facility Information:
Facility Name
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19816190
Citation
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.
Results Reference
result

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Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

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