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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

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