NCT00440973

Safety Study of Specific Tumor Target Drug Plus Immune System Therapy in Patients With Kidney Cancer

Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the combination of therapy to strengthen the immune system (Interleukin - 2) plus a specific tumor target therapy (Bevacizumab) can prolong the time between the start of treatment and disease progression, decrease tumor size, as well as determine if the combination therapy is safer and less toxic than the standard treatment for renal cell carcinoma.

Detailed description

The standard first-line treatment for patients with metastatic RCC is IL-2 at higher doses, but associated with higher frequency of toxicities. IL-2 given at lower doses have demonstrated similar results than higher doses but it requires further study. RCC is highly vascular and expresses high levels of VEGF. Bevacizumab is a monoclonal antibody directed against the Vascular Endothelial Growth Factor (VEGF) responsible for angiogenesis. The study is designed to evaluate a response defined as time to progression, safety and toxicity in patients with metastatic renal cell carcinoma. Tissue correlation to evaluate the impact of vascular VEGF on clinical outcome will be retrospectively performed

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Bevacizumab	monoclonal antibody with anti-angiogenesis properties used as chemotherapy
DRUG	Interleukin-2	immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T \& B lymphocyte proliferation

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-10-01
• Completion: 2007-11-01
• First posted: 2007-02-27
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States