A Phase 2 Study of Bevacizumab and Interferon-alpha-2b in Metastatic Malignant Melanoma
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. 95% confidence interval will be calculated.
Every 12 weeks
Ohio State University
United States: Food and Drug Administration
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