NCT00003067

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma. PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.

Trial Health

40
At Risk

Trial Health Score

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

Trial recruitment is currently suspended
Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 9, 2009

Status Verified

October 1, 2008

First QC Date

November 1, 1999

Last Update Submit

February 6, 2009

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult mixed gliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

aldesleukinBIOLOGICAL
lymphokine-activated killer cellsBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma) * Must be a candidate for neurosurgical biopsy or tumor debulking PATIENT CHARACTERISTICS: Age: * 18 and over Performance Status: * Karnofsky 60-100% Life Expectancy: * Greater than 4 months Hematopoietic: * Granulocytes greater than 1,500/mm\^3 * Platelet count greater than 50,000/mm\^3 * PT and PTT within normal limits Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal Renal: * Creatinine less than 1.5 mg/dL * Creatinine clearance greater than 60 mL/min Cardiovascular: * No congestive heart failure * No coronary artery disease * No serious cardiac arrhythmias * No prior myocardial infarction Pulmonary: * No major pulmonary problems Other: * No history of neurologic disease (except related to brain tumor) * No psychosis * No impaired cognitive function * No significant concurrent medical illness * No active infection requiring antibiotic therapy * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device * No hepatitis B or C * HIV negative * No prior autoimmune disease * Allergy to gentamicin is allowed PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 6 weeks since prior immunotherapy and recovered * No concurrent immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered * No concurrent chemotherapy Endocrine therapy: * Reduction or elimination of corticosteroids * Not greater than 0.15 mg/kg/day dexamethasone equivalent Radiotherapy: * At least 6 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * Prior surgery is allowed Other: * Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is 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)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Related Publications (1)

  • Hayes RL, Koslow M, Hiesiger EM, Hymes KB, Hochster HS, Moore EJ, Pierz DM, Chen DK, Budzilovich GN, Ransohoff J. Improved long term survival after intracavitary interleukin-2 and lymphokine-activated killer cells for adults with recurrent malignant glioma. Cancer. 1995 Sep 1;76(5):840-52. doi: 10.1002/1097-0142(19950901)76:53.0.co;2-r.

    PMID: 8625188RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaGliomaGliosarcoma

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

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

Study Officials

  • Roberta L. Hayes, PhD

    Immune Therapy, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

July 1, 1997

Last Updated

February 9, 2009

Record last verified: 2008-10

Locations

US(1)