UNITE Study: Understanding New Interventions With GBM ThErapy

Exclusion Criteria

• •Participant has received prior chemotherapy or radiotherapy for cancer of the head and neck region
• •Participant has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment
• •Participant has hypersensitivity to any component of temozolomide or dacarbazine
• •Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1
• •Participant has clinically significant uncontrolled condition(s) as described in the protocol
• •Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities
• •Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin
• •Participant has a history of herpetic keratitis
• •Participant is not suitable for receiving ocular steroids with conditions as described in the protocol
• •Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months
• •Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs)
• •Participant has hepatitis B virus or hepatitis C virus infection
• •Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV)