Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)

Exclusion Criteria

• •Chemotherapy (excluding nitrosourea, mitomycin C or vincristine), biologic therapy or immunotherapy within 4 weeks, inclusive, prior to study drug administration.
• •Nitrosourea or mitomycin C administration within 6 weeks, inclusive, prior to study drug administration.
• •Vincristine within 2 weeks prior to study drug administration.
• •Completion of radiation therapy, interstitial brachytherapy or radiosurgery within 4 weeks prior to study drug administration.
• •Surgery within 3 weeks, inclusive, prior to study drug administration.
• •Acute infection requiring intravenous antibiotics.
• •Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
• •Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
• •Known HIV positive or AIDS-related illness.
• •Pregnant or nursing women.
• •Men who are not advised to use an effective method of contraception.