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Home > "A" Clinical Trials Conditions > A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas  A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
For Condition: Brain Neoplasm,Astrocytoma,Glioma,Oligodendroglioma,Glioblastoma
Status: Recruiting
Sponsor(s): Pharmacyclics ,
Synopsis: 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 temolzolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 24
Location and Contact Information:
Barrow Neurological Institute *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting William Shapiro 602-456-7890
Additional Information:
Study ID Numbers: PCYC-0218;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080054
Other Glioblastoma Studies:
1. Procarbazine in Treating Patients With Recurrent Brain Tumor
2. Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas
3. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
4. STI571 to Treat Malignant Brain Tumors
Related Studies:
Other Glioblastoma Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
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