Clinical Trial Details
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NCT01587144 : Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)
PhasePhase 2
AgesMin: 18 Years Max: 70 Years
Main Inclusion Criteria:

1. 18 and 70 years of age

2. Histologically proven GBM who

- May or may not have undergone surgery

- Has at least one well demarcated bidimensional measurable lesion; and

- Is scheduled to receive treatment with temozolomide and radiation.

3. Karnofsky score ? 70%.

Main Exclusion Criteria:

1. Diagnosis of recurrent brain tumor.

2. Received temozolomide previously.

3. Absolute neutrophil count ? 1.5 X 109/L.

4. Screening platelet count < 100 K/uL.

5. Screening bilirubin > 1.6 mg/dL.

6. Screening creatinine > 2.25 mg/dL in men and 1.8 mg/dL in women.

7. Screening ALT or AST > 2.5 times the upper limit of the laboratory reference range.

8. 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.

9. Enrolled, or plans to enroll, in a concurrent treatment protocol with another
investigational product.

10. Receiving, or plans to receive, an anti-cancer therapy other than temozolomide during
the study.

11. Received prior chemotherapy or radiation therapy within four weeks of enrollment.
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