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Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00331526
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hoag Memorial Hospital Presbyterian
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Robert O. Dillman, MD, FACP
Principal Investigator Affiliation Hoag Memorial Hospital Presbyterian
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Newport Beach, California

Status

Address

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

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