NCT00026221

Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma

A Phase 2 Study of Bevacizumab and Interferon-Alpha-2b in Metastatic Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial is studying giving bevacizumab together with interferon alpha to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon alpha may interfere with the growth of the cancer cells and slow the growth of the tumor. Combining bevacizumab with interferon alpha may kill more tumor cells.

Detailed description

OBJECTIVES: I. Compare the objective response rate and progression-free survival in patients with metastatic malignant melanoma treated with bevacizumab with or without low- or high-dose interferon alpha. OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Patients also receive low-dose interferon alpha (IFN-alpha) subcutaneously (SC) on days 1-14. ARM II: Patients receive bevacizumab as in arm I. ARM III: Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12. In all arms, treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo restaging at the completion of course 12. Patients with stable disease or a clinical response may continue treatment according to their assigned treatment arm for up to 1 year. Patients with stable disease after 1 year of treatment with bevacizumab and IFN-alpha (arms I and III) may continue to receive bevacizumab alone every 21 days (as in arm II) in the absence of disease progression. Patients are followed every 3 months for 2 years.

Conditions

• Recurrent Melanoma
• Stage IV Skin Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Interferon Alfa	Given SC
BIOLOGICAL	Bevacizumab	Given IV

Timeline

• Start date: 2001-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2003-01-27
• Last updated: 2016-03-17
• Results posted: 2016-03-17

Locations

2 sites across 1 country: United States