Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery

NCT ID: NCT00814593

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-09-30

Brief Summary

RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating patients with glioblastoma multiforme.

PURPOSE: This randomized phase II trial is studying the side effects and how well lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with newly diagnosed glioblastoma multiforme that can be removed by surgery.

Detailed Description

OBJECTIVES:

• To compare the side effects, including infections and/or abnormal healing at the surgery site, associated with intralesional lymphokine-activated killer (LAK) cells vs polifeprosan 20 with carmustine implant (Gliadel® wafer) as consolidation therapy for patients with newly diagnosed resectable glioblastoma multiforme.
• To compare the overall survival of patients treated with these regimens.

OUTLINE: Patients are stratified according to age (< 50 vs ≥ 50 years of age), Karnofsky performance status (70-80% vs 90-100%), use of corticosteroids > 4 mg/day (yes vs no), and progressive disease during first-line therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.
• Arm II: Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy.

After completion of study treatment, patients are followed periodically for up to 5 years.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.

Group Type: EXPERIMENTAL

polifeprosan 20 with carmustine implant

Intervention Type: DRUG

Intracranial placement

Arm II

Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy.

Group Type: EXPERIMENTAL

lymphokine-activated killer cells

Intervention Type: BIOLOGICAL

Instilled into the tumor bed cavity

Interventions

lymphokine-activated killer cells

Instilled into the tumor bed cavity

Intervention Type: BIOLOGICAL

polifeprosan 20 with carmustine implant

Intracranial placement

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• No concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study
• No known hypersensitivity or allergy to either carmustine or aldesleukin

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 3 weeks since prior anticancer therapy and recovered
• No polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of prior surgery for GBM
• No prior treatment for progressive disease
• No other concurrent anticancer therapy (e.g., continuation of hormonal therapy for breast or prostate cancer that was diagnosed > 5 years ago)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lisata Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert O. Dillman, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

Caladrius Biosciences

Locations

Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Countries

United States

Other Identifiers

HOAG-HCC-08-01

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000630437

Identifier Type: -

Identifier Source: org_study_id