Trials / Completed
CompletedNCT00331526
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Hoag Memorial Hospital Presbyterian · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | aldesleukin | |
| BIOLOGICAL | therapeutic autologous lymphocytes | |
| PROCEDURE | adjuvant therapy | |
| PROCEDURE | conventional surgery |
Timeline
- Start date
- 1999-02-01
- Primary completion
- 2008-12-01
- Completion
- 2012-04-01
- First posted
- 2006-05-31
- Last updated
- 2013-03-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00331526. Inclusion in this directory is not an endorsement.