Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Melanoma
All patients will receive high-dose IL-2. Half the patients enrolled will be randomly
selected to receive radiation therapy to up to three tumors prior to receiving high-dose
IL-2. Among the first 20 patients enrolled, those assigned to receive radiation will
receive a single dose of radiation and for patients 21-44, those assigned to receive
radiation will receive 2 doses of radiation.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in diameter of target lesions
All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs, will be identified as target lesions and recorded and measured at baseline. Target lesions will be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the baseline, which will be used as reference by which to characterize the objective tumor response.
Within 28 days of starting treatment, after one course of IL-2 (7 weeks), and after each subsequent course of IL-2 (Weeks 14 and 21)
Brendan Curti, M.D.
Providence Health & Services
United States: Institutional Review Board
|Providence Cancer Center||Portland, Oregon 97213-2933|