A single-arm, phase II study of SU11248 (sunitinib) in patients with von Hippel-Lindau (VHL) disease. - VHLSUT

• Conditions: von Hippel-Lindau (VHL) disease; MedDRA version: 9.1Level: LLTClassification code 10047716Term: Von Hippel-Lindau disease

• Registration Number: EUCTR2009-013052-76-FR
• Lead Sponsor: ARTIC (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-26
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients must have genetically or clinically confirmed VHL disease and have symptoms from VHL that are no longer controllable by conventional approaches.
2.Patients must have at least one of the following lesions :
•Eye : retinal hemangioblastoma that can no longer be treated by laser therapy or cryotherapy and resulting in progressive loss of vision;
•CNS : cerebellar, bulbar, spinal, or cerebellopontine angle haemangioblastoma or endolymphatic sac tumor causing neurological symptoms that are not amenable to further surgery, or have recurred after a first surgery;
•Kidney: multiple or bilateral tumors not accessible to conservative surgery, or tumors having recurred after surgery and/or radiofrequency ablation or advanced/metastatic RCC;.
•Pancreas: inextirpable or advanced neuroendocrine tumors.
3.Patients previously treated for VHL with surgery, chemotherapy or radiotherapy are considered eligible for this study under the condition that these treatments were completed more than 4 weeks prior starting the study treatment. Previously radiated lesions will be considered as target lesions only if they demonstrate unequivocal evidence of growth upon imagery.
4.Male or female, at least 18 year-old.
5.Performance status ECOG 0-2
6.Life expectancy ? 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Chemotherapy, radiotherapy, radiofrequency or surgery within 4 weeks prior to entering the study or not complete recovering from adverse events due to drugs administered more than 4 weeks earlier.
4.Previous treatment with sunitinib
5.NCI-CTCAE grade ? 3 hemorrhage within 4 weeks prior to study entry.
6.History of known or suspected brain metastases, spinal cord compression, carcinomatous meningitis, evidence of leptomeningeal disease (excepted leptomeningeal hemangioblastoma, according to the neurologist) on screening CT scan or MRI.
7.Any of the following within the 6 months prior to study drug administration: symptomatic congestive heart failure, myocardial infarction or coronary artery bypass, pulmonary embolism, ongoing severe or unstable angina pectoris, NCI-CTCAE grade ? 2 cardiac dysrhythmia, cerebrovascular accident or transient ischemic attack.
8.Hypertension >140/90 mmHg that cannot be controlled despite optimal antihypertensive therapy.
13.Pregnancy or breastfeeding. Patients must agree to use effective contraception during the study, including oral contraceptives, intrauterine devices, or being unable to procreate.
14.Any other malignancy within the last 3 years excepted basal cell carcinoma, in situ cervical carcinoma, squamous cell skin cancer, pT1/a bladder cancer with no evidence of recurrence during the last 12 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified