NCT01436227

Pazopanib Hydrochloride in Treating Patients With Von Hippel-Lindau Syndrome

A Phase II Trial of Pazopanib in Von Hippel-Lindau Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with von Hippel-Lindau syndrome. Pazopanib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate safety and efficacy of treatment with pazopanib hydrochloride (pazopanib) for 6 months in patients with von Hippel-Lindau syndrome (VHL) who have a measurable VHL related lesion. SECONDARY OBJECTIVES: I. Evaluate rate of growth over time in target lesions before and after pazopanib treatment. II. Evaluate need for surgical intervention over time in patients who receive pazopanib and compare to rate prior to receipt of drug. III. Create an annotated tissue resource from patients with VHL for use in future research related to cancer. PRECLINICAL OBJECTIVES: I. Evaluate circulating factors in patients with VHL undergoing treatment with pazopanib. II. Evaluate relationship between VHL genotype and response to pazopanib. OUTLINE: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 4 weeks for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients benefitting from treatment may continue pazopanib hydrochloride in the absence of disease progression. After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 24 weeks.

Conditions

• Von Hippel-Lindau Syndrome

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Pazopanib Hydrochloride	Given PO

Timeline

• Start date: 2012-01-17
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2011-09-19
• Last updated: 2025-05-02
• Results posted: 2025-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study