NCT00004262

Brief Summary

Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

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

November 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

5.5 years

First QC Date

January 28, 2000

Last Update Submit

June 3, 2013

Conditions

Adult Giant Cell GlioblastomaAdult GlioblastomaAdult Gliosarcoma

Outcome Measures

Primary Outcomes (1)

  • Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0

    At the time of stereotactic radiosurgery

Secondary Outcomes (1)

  • Concentration of gadolinium in tumor, normal brain, and plasma by plasma-atomic emission spectroscopy and liquid chromatography with mass spectrometry

    At baseline, at 48 hours, and at 2 weeks post-surgery

Study Arms (1)

Treatment (motexafin gadolinium, radiotherapy, radiosurgery)

EXPERIMENTAL

Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.

Procedure: conventional surgeryRadiation: 3-dimensional conformal radiation therapyRadiation: stereotactic radiosurgeryDrug: motexafin gadoliniumProcedure: magnetic resonance imagingProcedure: spectroscopy

Interventions

conventional surgeryPROCEDURE
Also known as: surgery, conventional
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
3-dimensional conformal radiation therapyRADIATION
Also known as: 3D conformal radiation therapy, 3D-CRT
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
stereotactic radiosurgeryRADIATION
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
motexafin gadoliniumDRUG

Given IV

Also known as: gadolinium texaphyrin, Gd (III) Texaphryin, Gd-Tex, PCI-0120, Xcytrin
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
magnetic resonance imagingPROCEDURE

Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
spectroscopyPROCEDURE

Undergo plasma-atomic emission spectroscopy (DCP-AES)

Treatment (motexafin gadolinium, radiotherapy, radiosurgery)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed supratentorial glioblastoma multiforme by stereotactic biopsy, open biopsy, or resection
  • Maximum diameter of the tumor mass must be no greater than 4 cm in any dimension, including following debulking surgery
  • Tumor must be at least 1.0 cm from the optic chiasm and brainstem
  • No oligodendrogliomas, meningiomas, or grade I, II, or III astrocytomas
  • No infratentorial tumors
  • No multifocal glioblastoma multiforme
  • Tumor enhances on MRI
  • Must have visible tumor on postoperative MRI following surgical resection
  • Performance status - Karnofsky 60-100%
  • At least 3 months
  • Hemoglobin at least 10.0 g/dL
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 mg/dL
  • SGPT no greater than 60 U/L
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

GlioblastomaGliosarcoma

Interventions

Surgical Procedures, OperativeCongresses as TopicRadiotherapy, ConformalRadiosurgerymotexafin gadoliniumMagnetic Resonance SpectroscopySpectrum Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and OrganizationsRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresInvestigative TechniquesChemistry Techniques, Analytical

Study Officials

  • John Grecula

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2000

First Posted

January 27, 2003

Study Start

November 1, 1999

Primary Completion

May 1, 2005

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)