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CompletedNCT00331526Updated Mar 25, 2013

Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

A Phase 2 interventional study of aldesleukin and therapeutic autologous lymphocytes in Brain and Central Nervous System Tumors, sponsored by Hoag Memorial Hospital Presbyterian. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-03-25.

Sponsored by Hoag Memorial Hospital Presbyterian · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
83
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • adult glioblastoma
  • adult gliosarcoma
  • adult giant cell glioblastoma
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In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 83 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Hoag Memorial Hospital Presbyterian is the lead sponsor of 29 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
83 participants (actual)

Interventions

  • Biologicalaldesleukin
  • Biologicaltherapeutic autologous lymphocytes
  • Procedureadjuvant therapy
  • Procedureconventional surgery
06

What researchers measure

Primary outcomes

  1. Side effects and toxicity

  2. Progression-free survival and overall survival

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Study locations

1 site
  • Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92663, United States
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References and documents

Publications

  • Dillman RO, Duma CM, Ellis RA, Cornforth AN, Schiltz PM, Sharp SL, DePriest MC. Intralesional lymphokine-activated killer cells as adjuvant therapy for primary glioblastoma. J Immunother. 2009 Nov-Dec;32(9):914-9. doi: 10.1097/CJI.0b013e3181b2910f. PubMed 19816190 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00331526
Lead sponsor
Hoag Memorial Hospital Presbyterian
Responsible party
Sponsor
First posted
May 31, 2006
Start date
Feb 1999
Primary completion
Dec 2008
Completion
Apr 2012
Last update
Mar 25, 2013

Study contacts

Robert O. Dillman, MD, FACP
study chair · Hoag Memorial Hospital Presbyterian
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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