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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000738022

Acronym

TEMPT study

Enrollment

166

Registered

2010-09-06

Start date

2010-10-01

Completion date

2016-11-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results