Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00331526
• Lead Sponsor: Hoag Memorial Hospital Presbyterian

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.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Primary Completion: 2008-12
• Study Completion: 2012-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-22
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Side effects and toxicity
Progression-free survival and overall survival

Trial Locations

Locations (1)

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States