NCT00003842

Brief Summary

RATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma. PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in treating patients who have recurrent malignant astrocytoma.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

10 active sites

Status
unknown

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

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

September 14, 2004

Completed
Last Updated

December 18, 2013

Status Verified

June 1, 1999

First QC Date

November 1, 1999

Last Update Submit

December 17, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult giant cell glioblastomaadult gliosarcoma

Interventions

interleukin-4 PE38KDEL cytotoxinBIOLOGICAL
isolated perfusionDRUG
surgical procedurePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven recurrent glioblastoma or anaplastic astrocytoma Stereotactically accessible, enhancing mass no greater than 50 mL total volume by MRI No significant mass effect Recent craniotomy allowed No anaplastic oligodendroglioma No tumors of the brainstem, cerebellum, or both hemispheres No diffuse subependymal or CSF disease If on stable or increasing dose of steroid, must have evidence of increasing contrast enhancement by MRI or CT scan Prior external beam radiotherapy required PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9.5 g/dL Hepatic: Bilirubin less than 2 mg/dL AST and ALT less than 2 times upper limit of normal (ULN) PT/PTT no greater than ULN Renal: Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No systemic diseases to cause unacceptable anesthetic/operative risk No active infection requiring treatment No unexplained febrile illness PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent blood or platelet transfusions Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Medically able to undergo surgery Other: No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (10)

University of Southern California, Healthcare Consultation Center

Los Angeles, California, 90033, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128, United States

Location

Neuro-Oncology Service

San Francisco, California, 94143-0372, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Laboratory of Molecular Biology

Bethesda, Maryland, 20892, United States

Location

Food and Drug Administration

Rockville, Maryland, 20857, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Charlotte Neurosurgical Associates

Charlotte, North Carolina, 28207-1830, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaGliosarcoma

Interventions

interleukin-4-Pseudomonas exotoxinSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ronald E. Warnick, MD

    Barrett Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 14, 2004

Study Start

March 1, 1999

Last Updated

December 18, 2013

Record last verified: 1999-06

Locations

US(10)