NCT00430079

Brief Summary

This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma. Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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, 2001

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

6.2 years

First QC Date

January 30, 2007

Last Update Submit

January 15, 2013

Conditions

Adult Anaplastic AstrocytomaAdult Anaplastic EpendymomaAdult Anaplastic OligodendrogliomaAdult Diffuse AstrocytomaAdult EpendymomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Mixed GliomaAdult Myxopapillary EpendymomaAdult OligodendrogliomaAdult Pilocytic AstrocytomaAdult Pineal Gland AstrocytomaAdult Subependymoma

Outcome Measures

Primary Outcomes (1)

  • Time to local recurrence

    Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years

Secondary Outcomes (5)

  • Time to death

    Up to 3 years

  • Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses

    At 48 hours after EF5 administration

  • Levels of EF5 binding within histological subtypes of SMG

    At baseline, at 1 hour, and the time of surgery

  • Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)

    Up to 3 years

  • Association between EF5 binding and Eppendorf needle electrode measurements in brain masses

    Up to 3 years

Study Arms (1)

Diagnostic (etanidazole)

EXPERIMENTAL

Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.

Drug: etanidazoleProcedure: conventional surgeryOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

etanidazoleDRUG

Given IV

Also known as: 2-nitro-imidazole derivative, SR-2508
Diagnostic (etanidazole)
conventional surgeryPROCEDURE

Undergo surgery

Also known as: surgery, conventional
Diagnostic (etanidazole)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Diagnostic (etanidazole)
laboratory biomarker analysisOTHER

Correlative studies

Diagnostic (etanidazole)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed and/or clinical and imaging evidence of a new brain mass that is likely to be a supratentorial malignant glioma
  • Clinical condition and physiologic status indicative of debulking surgery or biopsy as standard initial therapy
  • Performance status - Karnofsky performance status 60-100%
  • WBC greater than 2,000/mm\^3
  • Platelet count greater than 90,000/mm\^3
  • Creatinine less than 2.0 mg/dL
  • No significant cardiac condition that would preclude study therapy
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study completion
  • Weight no greater than 130 kilograms
  • No grade 3 or 4 peripheral neuropathy
  • No other invasive malignancy within the past 3 years that is likely to cause a solitary supratentorial metastasis
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

AstrocytomaEpendymomaOligodendrogliomaGlioblastomaGliosarcomaGliomaGlioma, Subependymal

Interventions

EtanidazoleSurgical Procedures, OperativeCongresses as Topic

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOrganizationsHealth Care Economics and Organizations

Study Officials

  • Kevin Judy

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

July 1, 2001

Primary Completion

September 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)