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Completed

NCT Number: NCT00080054

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

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.

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Key information

Conditions

Glioma Astrocytoma Brain Diseases Brain Neoplasm Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Oligodendroglioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Motexafin Gadolinium Injection

Drug

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Registry information

Official study title

Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas

Important dates

First posted
Mar 23, 2004
Registry last updated
Apr 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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