Status:
COMPLETED
A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Glioma
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 gli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00080054
Last Update
April 3 2009
Active Locations (1)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013