Temozolomide Therapy for Aggressive Pituitary Tumours - a Phase 2 trial examining progression free survival, response rates and relationship of response to molecular biomarkers including 06-methylguanine-Deoxyribonucleic Acid (DNA) methyltransferase (MGMT).

Ann McCormack0 个研究点目标入组 35 人开始时间: 2010年9月6日最近更新: 2020年1月13日

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•Age > or = 18
•Patients must have failed standard therapies (surgery, radiotherapy, hormonal therapies) or be deemed unsuitable for such therapy
•Patients must have evidence of disease progression, clinically or radiologically, over a period of 12 months or less
•Patients with hypopituitarism must be stable on hormone replacement therapy
•Fertile patients must have a negative pregnancy test and males/females must use effective contraception for 1 month prior to and until 3 months following completion of temozolomide
•No clinically significant renal, haematologic or hepatic abnormalities

•Pituitary surgery or radiotherapy in the past 3 months
•No other new concurrent therapy to reduce pituitary tumour size
•Pregnant or breastfeeding
•Major surgery of any kind in the past 4 weeks
•Major comorbid illness, including other active malignant disease (exclusion at discretion of investigators)
•More than 1 prior course of chemotherapy with temozolomide for concurrent condition
•No active infection within the past 4 weeks (including known Human Immunodeficiency virus (HIV), Hepatitis B virus and C virus positivity)
•History of hypersensitivity to temozolomide or dacarbazine
•History of non-compliance with other therapies

发起方

Ann McCormack