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CompletedNCT00080054Updated Apr 3, 2009

A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas

A Phase 1 interventional study of Motexafin Gadolinium Injection in Glioma, Glioblastoma and Astrocytoma, sponsored by Pharmacyclics LLC.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-03.

Sponsored by Pharmacyclics LLC. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glioma
  • Glioblastoma
  • Astrocytoma
  • Oligodendroglioma
  • Brain Neoplasm

Keywords

  • Malignant Glioma
  • Glioblastoma multiforme
  • GBM
  • Anaplastic astrocytoma
  • AA
  • Anaplastic oligodendroglioma
  • Anaplastic mixed glioma
  • Brain tumor
  • Brain neoplasm
  • Glioma
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 24 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Pharmacyclics LLC. is the lead sponsor of 54 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants

Interventions

  • DrugMotexafin Gadolinium Injection
06

Study locations

1 site
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
07

References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00080054
Lead sponsor
Pharmacyclics LLC.
First posted
Mar 23, 2004
Last update
Apr 3, 2009
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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