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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie motexafin gadolinium's radiosensitizing effects in malignant gliomas?
How does the combination of motexafin gadolinium and temozolomide compare to standard temozolomide therapy in glioblastoma patients?
Are there specific biomarkers that predict response to motexafin gadolinium in astrocytoma or oligodendroglioma subtypes?
What are the most common adverse events associated with motexafin gadolinium and temozolomide combination therapy in brain tumor patients?
What other metal-based compounds or combination therapies are being explored for malignant gliomas alongside Pharmacyclics' research?
Trial Locations
- Locations (1)
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Barrow Neurological Institute🇺🇸Phoenix, Arizona, United States