NCT00003410

Brief Summary

RATIONALE: New imaging procedures such as the use of gadolinium texaphyrin with MRI may improve the ability to detect the extent of gliomas. PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin used with MRI-guided surgery in treating patients with high-grade glioma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 1998

Longer than P75 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

July 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2004

Completed
Last Updated

June 26, 2013

Status Verified

May 1, 2006

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

motexafin gadoliniumDRUG
magnetic resonance imagingPROCEDURE
surgical procedurePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Radiological diagnosis of probable high grade glioma, or biopsy proven high grade glioma, undergoing neurosurgery (biopsy or tumor resection) with interactive MRI guided control Must have an enhancing cerebral lesion No radiological diagnosis of metastases due to multiple lesions PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% while on steroids Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time no greater than 1.5 times upper limit of normal (ULN) Active partial thromboplastin time no greater than 1.5 times ULN Hepatic: Bilirubin no greater than 2 mg/dL AST and ALT no greater than 2 times ULN Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: No other significant life threatening disease No known glucose-6-phosphate dehydrogenase deficiency or porphyria No other active malignancy No intractable seizures Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Concurrent steroids allowed Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics Other: At least 48 hours since prior MRI scan with contrast No concurrent active agent or investigational drug No concurrent use of other study treatment Concurrent antiseizure medication allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

motexafin gadoliniumMagnetic Resonance SpectroscopySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Gregory Rubino, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 9, 2004

Study Start

July 1, 1998

Study Completion

June 1, 2004

Last Updated

June 26, 2013

Record last verified: 2006-05

Locations

US(1)