Von Hippel-Lindau Disease Clinical Trial
Official title:
A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease
VHL patients may benefit from sunitinib. This study will investigate the following
objectives :
PRIMARY OBJECTIVE
- To determine the objective response rate according to RECIST criteria, in VHL patients
with advanced tumors or tumors untreatable by other means, and treated with sunitinib.
SECONDARY OBJECTIVES
- To evaluate the safety and tolerability of sunitinib in VHL patients according to the
NCI-CTC criteria Version 3.0.
- To determine the following time-to-event endpoints: overall survival, time to disease
progression, progression free survival, time to response and duration of response.
- To evaluate quality of life in VHL patients receiving sunitinib.
Treatment with sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of
treatment followed by 2 weeks of rest).
Treatment until disease progression or unacceptable toxicity.
Dose reduction depending on type and severity of toxicity. At the end of treatment period
(after 8 courses), responding and well tolerating patients will be allowed to receive
sunitinib upon investigator's opinion.
Follow-up for up to 24 months from inclusion.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00970970 -
Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease
|
N/A | |
| Not yet recruiting |
NCT05737602 -
Promoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease
|
N/A | |
| Recruiting |
NCT05810246 -
68Ga-NY104 PET/CT in Von Hippel-Lindau Disease
|
Phase 2 | |
| Recruiting |
NCT06194669 -
Mechanisms of Somatic Mutation and Tumor Initiation in Pre-malignant Kidney Tubule Cells
|
||
| Recruiting |
NCT04074135 -
Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors
|
Phase 2 | |
| Enrolling by invitation |
NCT03979833 -
Drivers of Hypoxia-induced Angiogenesis in Tumor Development
|
||
| Active, not recruiting |
NCT04458935 -
Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma
|
||
| Recruiting |
NCT03749980 -
MyVHL: Patient Natural History Study
|
||
| Recruiting |
NCT05424016 -
Propranolol and Von Hippel-Lindau Disease
|
N/A | |
| Recruiting |
NCT02420067 -
Screening for Endolymphatic Sac Tumours (ELSTs) in Von Hippel-Lindau (vHL) Patients
|
N/A | |
| Completed |
NCT00052013 -
Treatment of Von Hippel-Lindau (VHL)-Related Hemangioblastoma With PTK787/ZK 222584
|
Phase 2 | |
| Recruiting |
NCT04924075 -
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
|
Phase 2 | |
| Recruiting |
NCT03050268 -
Familial Investigations of Childhood Cancer Predisposition
|
||
| Completed |
NCT02108002 -
Effect of Vorinostat on Nervous System Hemangioblastomas in Von Hippel-Lindau Disease (Missense Mutation Only)
|
Phase 1 | |
| Not yet recruiting |
NCT05843305 -
A Study of BPI-452080 in Subjects With Solid Tumors
|
Phase 1 | |
| Completed |
NCT03108066 -
PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT00062166 -
Natural History and Management of Pancreatic Lesions in Von Hippel-Lindau Disease
|