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

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IV Skin Melanoma

In brief

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.

Key facts

Study ID

NCT00026221

Run by

National Cancer Institute (NCI)

People needed

57

Starts

2001-11-01

Expected to finish

2013-11-01

Last updated by the study team

2016-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed cutaneous malignant melanoma
• Must meet one of the following criteria:
• Clinical evidence of metastatic disease
• Unresectable regional lymphatic disease
• Extensive in transit recurrent disease
• Measurable disease
• At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan
• No known brain metastases
• No ocular melanoma
• Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
• Performance status - Karnofsky 60-100%
• More than 6 months
• White blood cells (WBC) at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• No clinical evidence of coagulopathy
• Bilirubin =< 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's disease provided patient is stable and asymptomatic)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5 times upper limit of normal (ULN)
• Prothrombin time (PT)/International normalized ratio (INR) less than 1.5
• Creatinine =< 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• Protein < 1,000 mg on 24-hour urine collection for patients with proteinuria >= 1+
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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