NCT00080054

Brief Summary

The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 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

First Submitted

Initial submission to the registry

March 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
Last Updated

April 3, 2009

Status Verified

January 1, 2007

First QC Date

March 22, 2004

Last Update Submit

April 2, 2009

Conditions

GliomaGlioblastomaAstrocytomaOligodendrogliomaBrain Neoplasm

Keywords

Malignant GliomaGlioblastoma multiformeGBMAnaplastic astrocytomaAAAnaplastic oligodendrogliomaAnaplastic mixed gliomaBrain tumorBrain neoplasmGlioma

Interventions

Motexafin Gadolinium InjectionDRUG

Eligibility Criteria

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

You may qualify if:

  • At least 18 years old
  • Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma)
  • ECOG performance status score of 0, 1, or 2
  • Each patient must sign a study-specific informed consent form

You may not qualify if:

  • Laboratory values of:
  • Absolute neutrophil count \< 2000/µL
  • Platelet count \< 100,000/µL
  • AST or ALT \> 2 x the upper limit of normal (ULN)
  • Alkaline phosphatase \> 5 x ULN
  • Bilirubin \> 2 x ULN
  • Creatinine \> 2.0 mg/µL
  • and
  • Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
  • Women who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Related Links

MeSH Terms

Conditions

GliomaGlioblastomaAstrocytomaOligodendrogliomaBrain Neoplasms

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Neoplasms, 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

Study Design

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

Study Record Dates

First Submitted

March 22, 2004

First Posted

March 23, 2004

Last Updated

April 3, 2009

Record last verified: 2007-01

Locations

US(1)