Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331526
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2006-05-30
Brief Title:
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HOAG-CBRG-98-09 | None | None | None |