Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme

Inclusion Criteria

• •Must have biopsy-proven GBM. First relapse (progression or recurrence) of GBM after surgery (or biopsy) and treatment with radiotherapy (conventional fractionated external beam) and chemotherapy (temozolomide- or nitrosurea-based therapy)
• •Must have past biopsy samples available for central pathology review
• •Must have evidence on Gd-MRI of progressive/recurrent disease
• •Must have measurable disease on Gd-MRI obtained within 14 days prior to start of study treatment
• •Must be at least 18 years of age
• •Must have a Karnofsky Performance Status score of at least 70
• •If being treated with steroids, the steroid dose must be stable or decreasing for 1 week prior to randomization
• •If being treated with anticonvulsants, must have no change in the type of anticonvulsants for 2 weeks prior to randomization
• •All acute toxic effects (except for alopecia) of any prior treatment must have resolved or are no greater than grade 1 (NCI Common Toxicity Criteria, Version 2.0)
• •Baseline laboratory data must be within the following limits: absolute neutrophil count at least 1500; platelets at least 100,000; hemoglobin at least 9.0 g/dL; serum creatinine no greater than 1.5 mg/dL, total serum bilirubin no greater than 1.5 times the upper limit of the normal range; SGOT and SGPT no greater than 2.5 times the upper limit of the normal range; albumin at least 3.0 g/dL, serum or urine pregnancy test (for females of childbearing potential) negative within 7 days prior to start of study treatment
• •At least 6 weeks must have elapsed since completion of prior nitrosurea therapy; at least 4 weeks since completion of prior temozolomide therapy
• •Must have written informed consent
• •Must be able and willing to comply with study procedures
• •\	Must have received prior treatment with radiotherapy (conventional fractionated external beam) and (neo)adjuvant/concurrent chemotherapy (with a temozolomide- or a nitrosurea-based containing )regimen for GBM