NCT00089427

Brief Summary

This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery (CED) to the area around the tumor site after the tumor is surgically removed (resection). In addition, the patient will receive radiation therapy and may or may not be treated with oral temozolomide.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

6 active sites

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

July 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

July 4, 2011

Status Verified

April 1, 2011

Enrollment Period

3 years

First QC Date

August 5, 2004

Last Update Submit

June 30, 2011

Conditions

Glioblastoma MultiformeAnaplastic AstrocytomaOligoastrocytoma

Keywords

brain tumormalignant gliomabrain neoplasmcentral nervous systemsurgeryresectiontemozolomideinfusionglioblastoma multiformeanaplastic astrocytomaoligoastrocytomaTemodarradiationconvection-enhanced deliveryGBM

Interventions

IL13-PE38QQRDRUG
Surgery for placementPROCEDURE
Radiation therapyPROCEDURE
Temozolomide with radiation therapyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be ≥18 years old.
  • Patients must have undergone a gross total resection of the solid contrast-enhancing lesion(s) \> 1.0 cm in diameter.
  • Patients must be able to have catheters placed within 14 days of tumor resection (including a planned Gross Total Resection following an initial biopsy or subtotal resection)
  • Patients must have histopathologic confirmation of malignant glioma from resection specimen. Diagnosis must be consistent with either GBM, AA, or malignant mixed OA.
  • Patients must be in adequate general condition and meet the following criteria:
  • a. Karnofsky Performance Scale score ≥ 70
  • b. Adequate hematologic status:
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 10 gm/dL
  • Platelets ≥ 100,000/mm³
  • PT \& aPTT within institutional limits of normal
  • Female patients must not be pregnant or breast-feeding.
  • Patients must practice an effective method of birth control during the study and for 60 days beyond the last day of infusion.
  • Patients must understand the investigational nature of this study and its potential risks and benefits, and sign an approved written informed consent prior to performance of any study-specific procedure.

You may not qualify if:

  • Patients with residual contrast-enhancing tumor crossing the midline, multifocal tumor not amenable to gross total resection or non-parenchymal tumor dissemination (e.g., subependymal or leptomeningeal).
  • Patients with clinically significant increased ICP (e.g., impending herniation), uncontrolled seizures or requirement for immediate palliative treatment.
  • Patients who have received any prior anti-tumor treatment (other than corticosteroids) including any investigational agents.
  • Patients with any metallic prosthesis that would prevent MRI and/or MRS scanning procedures of the brain.
  • Patients unwilling or unable to follow protocol requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California San Francisco - Dept. of Neurological Surgery

San Francisco, California, 94143, United States

Location

Carolina Neurosurgery & Spine Assoc.

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation Department of Neurological Surgery

Cleveland, Ohio, 44195, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia Health Systems - Department of Neurological Surgery

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

GlioblastomaAstrocytomaBrain NeoplasmsGlioma

Interventions

IL13-PE38Surgical Procedures, OperativeDrug ImplantsRadiotherapyTemozolomide

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical PreparationsTherapeuticsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2004

First Posted

August 6, 2004

Study Start

July 1, 2004

Primary Completion

July 1, 2007

Last Updated

July 4, 2011

Record last verified: 2011-04

Locations

US(6)