Temozolomide Therapy for Aggressive Pituitary Tumours
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 McCormack
35 participants
Oct 1, 2010
Interventional
Conditions
Summary
The primary purpose of this study is to determine the effectiveness of temozolomide therapy in the management of aggressive pituitary tumours. Case reports have suggested that temozolomide may be efficacious in the treatment of pituitary tumours, and this needs to be tested now in a prospective controlled trial with larger patient numbers. In addition, this trial will determine whether there are molecular markers present in tumour tissue that may help predict which patients will benefit most from this therapy.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria9
- 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
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Interventions
Temozolomide. Oral administration. Patients receive 150mg/m2 for first 5 days of Cycle 1, and if this is tolerated they receive 200mg/m2 daily for 5 days every 28 days of subsequent treatment cycles. Minimum duration 6 months. Length of therapy at discretion of treating clinician.
Locations(1)
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ACTRN12610000738022