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An International, Multi-Center, Randomized, Double Blind Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of Lucanthone Administered as an Adjunct to Radiation and Temozolomide for Primary Therapy of Glioblastoma Multiforme
|Temozolomide (SCH 52365)
- To determine the efficacy of lucanthone when given along with temozolomide (TMZ) and radiation in the primary treatment of GBM due for radiation and TMZ treatment.
- To evaluate the safety and toxicity of lucanthone when used in combination with temozolomide (TMZ) and radiation in primary treatment of GBM due for radiation and TMZ treatment.
A patient will be eligible for study participation only if all of the following criteria apply:
- The patient has given informed consent. (A signed consent form that has been approved by an IRB/IEC is required prior to the performance of any protocol-related procedures or assessments)
- The patient is willing and able to abide by the protocol.
- The patient is between age 18 and 70 (both included).
- The patient has histologically proven GBM who a) may or may not have undergone surgery,b) is scheduled to receive treatment with temozolomide and radiation.
- If the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception.
- If the patient is a female of childbearing potential, she has a negative serum pregnancy test.
- The patients Karnofsky score is ≥ 70%.
A patient will not be eligible for study participation if any of the following criteria apply:
- Patient has a diagnosis of recurrent brain tumor.
- The patient has received temozolomide previously.
- The patient has an absolute neutrophil count less than or equal to 1.5 X 10^9/L.
- The patient has a screening platelet count less than 100 K/uL.
- The patient has a screening bilirubin greater than 1.6 mg/dL.
- The patient has a screening creatinine greater than 2.25 mg/dL in men and 1.8 mg/dL in women.
- The patient has a screening alanine aminotransferase (ALT), or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of the laboratory reference range.
- The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
- The patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
- The patient is receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study.
- The patient has received prior chemotherapy or radiation therapy within four weeks of enrollment.
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