A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
Phase 1
Completed
- Conditions
- GliomaGlioblastomaAstrocytomaOligodendrogliomaBrain Neoplasm
- Registration Number
- NCT00080054
- Lead Sponsor
- Pharmacyclics LLC.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States