Paraganglioma Clinical Trial
Official title:
A Phase I Trial of Vandetanib Combined With 131I-mIBG Radiotherapy in Patients With Neuroendocrine Tumours, Advanced Phaeochromocytoma and Paraganglioma
The phase I trial aims to determine the recommended phase II dose (RP2D) of vandetanib in combination with standard radiation therapy, 131I-mIBG, in patients with advanced phaeochromocytoma (phaeo) and paraganglioma (PG) by assessing the safety and tolerability of the combination treatment.
VIBRaNT is a registered phase I trial in patients with locally advanced or metastatic
phaeochromocytoma or paraganglioma, not amenable to surgical resection.
Patients will receive vandetanib (an inhibitor of VEGF, EGFR and RET tyrosine kinase) in
combination with standard radiation therapy Iodine-131 labelled Meta-iodobenzylguanidine
(131I-mIBG).
Vandetanib and 131I-mIBG will be given in 12-weekly cycles: 131I-miBG will be given on day 1
of each cycle and vandetanib will started on day 1 of each cycle and continue to be taken
once every day. The phase I trial aims to determine with recommended phase II dose of
vandetanib (either 100, 200 or 300 mg once daily) - the dose of vandetanib that patients
will receive will depend on the dose under investigation at the time of patient
registration.
The vandetanib dose will be determined by the Modified Continual Reassessment Method (mCRM)
- a toxicity model which described the probability of a toxicity occurring at each dose
level, which is based on clinical judgement and any available toxicity data.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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