NCT00331526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 25, 2013

Status Verified

March 1, 2013

Enrollment Period

9.8 years

First QC Date

May 30, 2006

Last Update Submit

March 22, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult gliosarcomaadult giant cell glioblastoma

Outcome Measures

Primary Outcomes (2)

  • Side effects and toxicity

  • Progression-free survival and overall survival

Interventions

aldesleukinBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Related Publications (1)

  • 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.

    PMID: 19816190RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

aldesleukinChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Robert O. Dillman, MD, FACP

    Hoag Memorial Hospital Presbyterian

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

February 1, 1999

Primary Completion

December 1, 2008

Study Completion

April 1, 2012

Last Updated

March 25, 2013

Record last verified: 2013-03

Locations

US(1)