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

Completed · Phase 1

Conditions studied: Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasm

In brief

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.

Key facts

Study ID

NCT00080054

Run by

Pharmacyclics LLC.

People needed

24

Last updated by the study team

2009-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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