VIBRaNT
Research type
Research Study
Full title
A phase I trial of Vandetanib combined with 131I-mIBG Radiotherapy in patients with Neuroendocrine Tumours, advanced phaeochromocytoma and paraganglioma
IRAS ID
131552
Contact name
Christina Thirlwell
Contact email
Sponsor organisation
University College London
Eudract number
2013-001017-33
Clinicaltrials.gov Identifier
Research summary
The VIBRaNT trial will be looking at combining vandetanib, a drug licensed for the treatment of medullary thyroid cancer (MTC) and tumours with Rearranged during Transfection (RET) mutation (such as with phaeochromocytomas and paragangliomas), with standard radiation therapy 131I-mIBG, to see if treating patients with phaeochromocytomas (phaeos) and paragangliomas (PGs) with vandetanib and 131I-mIBG is safe and does not cause too many side effects, and if it is better for treating phaeos and PGs than 131I-mIBG alone.
The purpose of the phase I trial is to assess how well the combination of vandetanib and 131I-mIBG is tolerated when given together. This is a dose escalation trial which aims to determine the recommended dose of vandetanib to give when combined with 131I-mIBG.
Patients will be asked to consent to give extra blood samples to see if biomarkers can be identified to learn more about how the drugs work to shrink cancers, and extra blood and urine samples for central review of metanephrines.
131I-mIBG will be given every 12 weeks intravenously (through the vein). Vandetanib tablets will be taken by mouth once daily. Scans, blood tests and regular examinations will be performed prior to and throughout treatment to see if the treatment is working and ensure that it is safe to continue. Patients may receive up to 4 cycles of 131I-mIBG and vandetanib combination treatment. All patients will be followed for up to three years from the date of registration in the absence of disease progression.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0311
Date of REC Opinion
23 Apr 2014
REC opinion
Further Information Favourable Opinion