331526
Last Update Posted: 2013-03-25
Recruiting has ended
All Genders accepted | 16 Years + |
83 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
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.
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.
Eligibility
Relevant conditions:
Brain and Central Nervous System Tumors
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov