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Trial registered on ANZCTR


Registration number
ACTRN12610000738022
Ethics application status
Approved
Date submitted
10/08/2010
Date registered
6/09/2010
Date last updated
15/11/2018
Date data sharing statement initially provided
15/11/2018
Date results information initially provided
15/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Temozolomide Therapy for Aggressive Pituitary Tumours
Scientific title
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).
Secondary ID [1] 252423 0
Nil
Universal Trial Number (UTN)
Trial acronym
TEMPT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aggressive Pituitary Tumours 257931 0
Condition category
Condition code
Cancer 258101 258101 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256986 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258962 0
Progression free survival as assessed by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
Timepoint [1] 258962 0
6 months following start of temozolomide therapy.
Secondary outcome [1] 265139 0
Tumour response rate (complete or partial) as assessed by RECIST criteria utilising Magnetic Resonance Imaging (MRI)
Timepoint [1] 265139 0
3, 6, 9 and 12 months after start of temozolomide therapy
Secondary outcome [2] 265140 0
Time to progression as assessed by RECIST criteria utilising MRI
Timepoint [2] 265140 0
3,6,9 and 12 months after start of temozolomide therapy AND 3,6,9 and 12 months following completion of temozolomide therapy.
Secondary outcome [3] 265141 0
Control of tumour hormone hypersecretion as measured by blood analysis of hormone levels (Prolactin, Growth Hormone, Insulin-like growth factor 1, Thyroid Stimulating Hormone, Free thyroxine, Adrenocorticotropic hormone, Cortisol, Follicle Stimulating Hormone, Luteinising Hormone, oestradiol/testosterone).
Timepoint [3] 265141 0
3,6,9 and 12 months following start of temozolomide therapy and at 3,6,9 and 12 months following completion of temozolomide therapy
Secondary outcome [4] 265142 0
Safety and tolerability of temozolomide as assessed by proportion of patients with grade 3 or 4 toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0
Timepoint [4] 265142 0
Assessed at each monthly visit whilst on temozolomide therapy
Secondary outcome [5] 265143 0
Exploratory analysis of novel biomarkers, proteomic profiling and MRI imaging correlated with known outcome measures as above
Timepoint [5] 265143 0
Completion of trial

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2812 0
United Kingdom
State/province [1] 2812 0

Funding & Sponsors
Funding source category [1] 257438 0
Self funded/Unfunded
Name [1] 257438 0
Nil
Address [1] 257438 0
Nil
Country [1] 257438 0
Primary sponsor type
Individual
Name
Ann McCormack
Address
Cancer Genetics Unit
Kolling Institute of Medical Research
Royal North Shore Hospital
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 256668 0
None
Name [1] 256668 0
Nil
Address [1] 256668 0
Nil
Country [1] 256668 0
Other collaborator category [1] 251429 0
Individual
Name [1] 251429 0
Professor Ashley Grossman
Address [1] 251429 0
Centre for Endocrinology
5th Floor King George V Building
St Bartholemew's Hospital
London
EC1A 7BE
Country [1] 251429 0
United Kingdom
Other collaborator category [2] 251430 0
Individual
Name [2] 251430 0
Professor John Wass
Address [2] 251430 0
Oxford Centre for Diabetes and Endocrinology
University of Oxford
Churchill Hospital
Headington
Oxford
OX3 7LJ
Country [2] 251430 0
United Kingdom
Other collaborator category [3] 251431 0
Individual
Name [3] 251431 0
Dr Stephanie Baldeweg
Address [3] 251431 0
Department of Diabetes & Endocrinology
University College Hospital National Health Service (NHS) Foundation Trust
3rd Floor Central
London
NW1 2PQ
Country [3] 251431 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259463 0
Hawkesbury Human Research Ethics Committee (HREC) Northern Sydney Central Coast Area Health
Ethics committee address [1] 259463 0
Ethics committee country [1] 259463 0
Australia
Date submitted for ethics approval [1] 259463 0
28/07/2010
Approval date [1] 259463 0
01/08/2010
Ethics approval number [1] 259463 0
1007-254M

Summary
Brief 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.
Trial website
Trial related presentations / publications
European Journal of Endocrinology (2018) 178, 265–276
Public notes

Contacts
Principal investigator
Name 31506 0
Address 31506 0
Country 31506 0
Phone 31506 0
Fax 31506 0
Email 31506 0
Contact person for public queries
Name 14753 0
Dr Ann McCormack
Address 14753 0
Cancer Genetics Unit
Kolling Institute of Medical Research
Royal North Shore Hospital
St Leonards
NSW 2065
Country 14753 0
Australia
Phone 14753 0
61 2 9926 4763
Fax 14753 0
Email 14753 0
mccormackann007@gmail.com
Contact person for scientific queries
Name 5681 0
Dr Ann McCormack
Address 5681 0
Cancer Genetics Unit
Kolling Institute of Medical Research
Royal North Shore Hospital
St Leonards
NSW 2065
Country 5681 0
Australia
Phone 5681 0
61 2 9926 4763
Fax 5681 0
Email 5681 0
mccormackann007@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary