NCT01048554

Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System

A Phase II Trial of Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This research is being done because melanoma in the brain is very difficult to treat because it does not respond to radiation or to chemotherapy, such as temozolomide. One of the reasons for this is that the melanoma can make chemicals that signal the brain to provide new blood vessels for the tumor. The main signal is called VEGF. Bevacizumab is an antibody that blocks VEGF. The investigators want to see if the combination of bevacizumab and temozolomide will stop the melanoma from growing.

Detailed description

This study proposes the use of a combination of temozolomide and bevacizumab in a carefully selected group of patients with metastatic melanoma to the brain. This combination has been tested in primary brain tumors and in melanoma not involving the brain. The 6-week on, 2-week off low-dose schedule proposed in this trial capitalizes on preclinical data demonstrating that temozolomide inhibits angiogenesis at low, non-toxic doses that correspond to the plasma concentrations achieved by an oral administration, a so-called 'metronomic' scheduling. The precise mechanism of its antiangiogenic action remains to be elucidated. This potential synergistic mechanism, together with the bulk of evidence for activity presented above suggests that the combination will be well-tolerated, safe and possibly more effective.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Temozolomide 75mg/m2 for six continuous weeks
DRUG	Bevacizumab	Bevacizumab 10mg/kg every 2 weeks without interruption

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-01-13
• Last updated: 2012-04-19

Locations

3 sites across 1 country: United States