CompletedPhase 2ACTRN12610000738022

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).

Sponsor

Ann McCormack

Enrollment

35 participants

Start Date

Oct 1, 2010

Study Type

Interventional

Conditions

Aggressive Pituitary Tumours

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a chemotherapy drug (temozolomide) for aggressive pituitary tumours that have not responded to standard treatments like surgery, radiation, or hormone therapy. You must be 18 or older with a pituitary tumour that is growing despite previous treatments. Pregnant women, people who had brain surgery in the last 3 months, or those with active infections cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.

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)

United Kingdom

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12610000738022