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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04081701 -
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
|
Phase 4 | |
| Recruiting |
NCT05636618 -
Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT05948137 -
F-18 FDOPA PET/CT Versus I-123 MIBG Scintigraphy With SPECT/CT for the Diagnosis of Pheochromocytoma and Paraganglioma
|
||
| Recruiting |
NCT05069220 -
18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor
|
Early Phase 1 | |
| Recruiting |
NCT04573816 -
Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma
|
||
| Active, not recruiting |
NCT04400474 -
Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study
|
Phase 2 | |
| Not yet recruiting |
NCT06045260 -
"Receptor Radionuclide Therapy With 177Lu-DOTATOC
|
Phase 2 | |
| Completed |
NCT01204476 -
Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma
|
Phase 1 | |
| Completed |
NCT01967576 -
Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma
|
Phase 2 | |
| Recruiting |
NCT03160274 -
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
|
||
| Recruiting |
NCT03206060 -
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
|
Phase 2 | |
| Not yet recruiting |
NCT04788927 -
Development of a Predictive Model for the Risk of Metastatic Disease in PPGLs, a Retrospective Cohort Study
|
||
| Recruiting |
NCT04119024 -
Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01022515 -
Specificity of Elevated Plasma EM66 Levels in Pheochromocytoma
|
N/A | |
| Completed |
NCT00188019 -
Hereditary Paraganglioma: Evaluation of Screening Methods to Detect Tumors in SDH Positive Carriers
|
N/A | |
| Recruiting |
NCT06155734 -
Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green
|
||
| Recruiting |
NCT04891081 -
Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease
|
||
| Recruiting |
NCT04017104 -
Dynamic Whole Body Positron Emission Tomography/Computed Tomography Imaging
|
||
| Recruiting |
NCT03344016 -
Multicenter Pheochromocytoma and Paraganglioma Evaluation
|
N/A | |
| Completed |
NCT03176693 -
Preoperative Alpha Blockade for Pheochromocytoma
|
Phase 3 |