Adjuvant Therapy for Patients With Primary Uveal Melanoma With Genetic Imbalance
I. Assess disease-free survival (DFS) with sequential dacarbazine and interferon-alfa-2b as
an adjuvant to primary therapy for patients with uveal melanoma with genetic imbalance.
I. Evaluate side effects and assess safety in the patient population.
II. Examine the relationship between the levels of plasma biomarkers of immune function and
tumor invasion and the clinical outcome.
OUTLINE: Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the
second dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3
times a week for 24 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
DFS will be calculated from the date treatment starts to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier. Treatment will be considered relatively ineffective in this population if the underlying 2-year DFS is <60%, whereas the combination will be considered promising if the underlying rate is >80%.
2 yrs from start of treatment
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Federal Government
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|