Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

March 22, 2013 updated by: Hoag Memorial Hospital Presbyterian

Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of primary malignant glioblastoma multiforme (i.e., grade IV anaplastic astrocytoma)
  • Primary treatment (surgery, radiation, and/or chemotherapy) has been completed
  • Candidate for surgery and willing to undergo craniotomy
  • No progressive or recurrent disease
  • No residual disease that requires reoperation, additional gamma therapy, or other modality

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% (i.e., if symptomatic, bedridden < half of a waking day)
  • Life expectancy ≥ 2 months
  • Not pregnant
  • Negative pregnancy test
  • U.S. residents only
  • No hematopoietic, hepatic, renal, cardiovascular, or pulmonary laboratory values or other medical circumstances that would preclude surgery or aldesleukin therapy
  • No serious concurrent medical or psychiatric illness that would preclude informed consent or study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior anticancer therapy and recovered
  • Prior stereotactic or gamma knife radiosurgery allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival and overall survival
Side effects and toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoag Memorial Hospital Presbyterian

Investigators

  • Study Chair: Robert O. Dillman, MD, FACP, Hoag Memorial Hospital Presbyterian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (Estimate)

May 31, 2006

Study Record Updates

Last Update Posted (Estimate)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 22, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000471241
  • HOAG-CBRG-98-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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