A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years old
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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)
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ECOG performance status score of 0, 1, or 2
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Each patient must sign a study-specific informed consent form
Exclusion Criteria:
Laboratory values of:
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Absolute neutrophil count < 2000/µL
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Platelet count < 100,000/µL
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AST or ALT > 2 x the upper limit of normal (ULN)
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Alkaline phosphatase > 5 x ULN
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Bilirubin > 2 x ULN
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Creatinine > 2.0 mg/µL
and
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Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
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Women who are pregnant or lactating
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Barrow Neurological Institute | Phoenix | Arizona | United States | 85013 |
Sponsors and Collaborators
- Pharmacyclics LLC.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- PCYC-0218