NCT00283543

Brief Summary

To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

January 26, 2006

Last Update Submit

October 30, 2007

Conditions

Newly Diagnosed Supratentorial Malignant Glioma

Keywords

GliomaGliadel Wafer

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and efficacy of Gliadel 3.85% wafers

Interventions

Gliadel WaferDRUG
TemozolomideDRUG
Limited field radiationPROCEDURE

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MRI showing unilateral supratentorial cerebral tumor
  • surgical tx within 4 weeks of baseline MRI
  • KPS 60% or higher
  • moderate to high grade malignant glioma

You may not qualify if:

  • prior cytoreductive surgery for moderate or high grade glioma
  • prior CNS radiotherapy
  • prior chemo for this glioma
  • more than one focus of tumor or tumor crossing the midline per MRI
  • life expectancy less than 12 months
  • sensitivity to temozolomide, nitrosoureas, or Gliadel wafer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kentuckiana Cancer Institute

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

CarmustineTemozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsDacarbazineTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Renato V. LaRocca, MD

    Kentuckiana Cancer Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 30, 2006

Study Start

September 1, 2002

Study Completion

April 1, 2008

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

US(1)