The Florida Melanoma Trial: A Phase I/II Trial of Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa in the Treatment of Advanced Stage III Melanoma: Study Site & Coordinating Center
OBJECTIVES: I. Determine the effectiveness and toxicity of adjuvant radiotherapy given
concurrently with interferon alfa to patients with stage III or recurrent melanoma.
OUTLINE: This is a multicenter study. Patients receive interferon alfa IV over 20 minutes
daily for 5 consecutive days a week for 4 weeks. Patients then receive radiotherapy on days
2 and 4 and interferon alfa subcutaneously (SQ) on days 1, 3, and 5 for 2.5 weeks.
Interferon alfa SQ continues 3 times a week for 10 months in the absence of disease
progression or unacceptable toxicity. Patients are followed every month for 3 months, then
every 3 months for 2 years, then every six months until year 5, and then annually
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2.75 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Study Duration: 7 years
Ronald C. DeConti, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Sylvester Cancer Center, University of Miami||Miami, Florida 33136|