Conditions: Renal Cell Carcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief summary:
This is a phase II study of an investigational agent, brivanib, in patients with refractory metastatic renal cell carcinoma. This study will evaluate the safety and effectiveness of brivanib in renal cell carcinoma, and explore the activity of this drug in this population to determine whether imaging and molecular features of the tumors can be used to predict response. Approximately 30 people with advanced kidney cancer will be enrolled on this study at the University of Pennsylvania.

Detailed description:
The primary objective of this clinical trial is to determine the efficacy of brivanib in the treatment of metastatic renal cell carcinoma in terms of progression-free survival (PFS) in patients who have progressed on treatment with sunitinib, sorafenib, bevacizumab, or pazopanib. The primary endpoint of the trial will be PFS at 16 weeks. The secondary objectives are to further examine the safety and tolerability profile of brivanib, to examine the efficacy of brivanib in this population in terms of best overall response, response rate, progression-free survival, and overall survival, to describe baseline and changes in I-cG250 PET/CT in relation to observed therapeutic effects, to describe novel baseline histologic features of these tumors in relation to observed therapeutic effects. Modalities will include Von Hippel-Lindau gene (VHL) and hypoxia-inducible factor 1 gene (HIF-1) expression assessment and a novel histo-cytometric assessment of the tumor microenvironment in terms of p-STAT3, p-ERK, Ki67, VEGFR2, FGFR1 expression, to describe changes in circulating collagen IV on brivanib in relation to therapeutic effects, to explore the relationship between single nucleotide polymorphisms in angiogenesis-related genes and the activity of brivanib in the treatment of these patients.

Arms:
arm 1: Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: Brivanib alaninate intervention 2: Polymerase chain reaction intervention 3: Iodine I 124 chimeric monoclonal antibody G250 intervention 4: Positron emission tomography/computed tomography intervention 5: Protein expression analysis intervention 6: Immunohistochemistry
Intervention descriptions: intervention 1: Brivanib by mouth daily at a dose of 800mg. intervention 2: Undergo 1241-cG250 PET/CT imaging (correlative studies) intervention 3: Undergo 124I-cG250 PET/CT imaging (correlative studies) intervention 4: Undergo 1241-cG250 PET/CT imaging (correlative studies) intervention 5: Correlative studies intervention 6: correlative studies

Protocol document: