Temozolomide Therapy for Aggressive Pituitary Tumours

Phase 2

Completed

• Conditions: Aggressive Pituitary Tumours; Cancer - Other cancer types

• Registration Number: ACTRN12610000738022
• Lead Sponsor: Ann McCormack

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival as assessed by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.[6 months following start of temozolomide therapy.]