NCT00376103

Brief Summary

The purpose of this study is to determine treatment related toxicity, tumor response, progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme (GBM) patients undergoing a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1

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

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

1.6 years

First QC Date

September 13, 2006

Last Update Submit

September 17, 2009

Conditions

Glioblastoma Multiforme

Keywords

Brain TumorGBMGlioblastoma MultiformeGlioblastomaBrachytherapyTemozolomideTemodar

Outcome Measures

Primary Outcomes (1)

  • Treatment-related toxicity.

    1 year

Secondary Outcomes (4)

  • 6 month, 1 year and overall survival.

    End of study

  • Tumor progression.

    End of study

  • Progression-free survival.

    End of study

  • Quality of life.

    End of study

Interventions

temozolomideDRUG

75 mg/m2/day

Also known as: Temodar
BrachytherapyPROCEDURE

60 Gy to 1 cm

External Beam Radiation TherapyPROCEDURE

60 Gy

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed, unifocal, unilateral, supratentorial lesion seen on MRI and suspicious for Glioblastoma Multiforme
  • Subject must be a candidate for surgical resection of the tumor mass with feasible gross total resection
  • Age 18 years or older
  • Subject must be an appropriate candidate to receive brachytherapy and temozolomide per the GliaSite RTS and temozolomide IFU
  • The tumor must be histopathologically confirmed by intra-operative frozen section and by final pathology
  • Karnofsky Performance Status (KPS) =\> 70
  • Negative pregnancy test if a female of childbearing age and not surgically sterilized
  • Male or female subject agrees to use acceptable birth control methods while receiving treatment (if not surgically sterile)
  • Life expectancy \> 3 months
  • Adequate laboratory results: ANC =\> 1.5 x 109/L. Platelets =\> 100 x 109/L
  • Subject or legal representative must provide informed consent and HIPAA authorization prior to surgery

You may not qualify if:

  • Prior use of temozolomide
  • Presence or history of severe hepatic or renal impairment
  • Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea and vomiting
  • Subject with prior intracranial malignancy
  • Major medical illness or psychiatric impairments that in the investigators opinion will prevent administration or completion of the protocol therapy
  • Subject has pacemaker or other MRI non-compatible metal in the body
  • Previous radiation to the head/neck or brain
  • Pregnant or lactating women
  • Patient has allergy to iodine and/or dacarbazine
  • Creatinine \> 1.5x upper limits of normal (ULN), AST \> 3x ULN
  • Chemotherapy within the last 6 months
  • Residual tumor \>1 cm (in a single dimension) on baseline MRI scan (T1 post-gadolinium images)
  • Balloon surface within 1 cm of critical structure (brain stem, midbrain, optic chiasm) on baseline MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

GlioblastomaBrain Neoplasms

Interventions

TemozolomideBrachytherapy

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, 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)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRadiotherapyTherapeutics

Study Officials

  • Allen K Sills, MD

    Methodist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 14, 2006

Study Start

August 1, 2006

Primary Completion

March 1, 2008

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

US(1)