D0320: High Dose Interleukin-2 (IL-2) Therapy in "Lymphodepleted Primed" Patients With Metastatic Melanoma
After meeting eligibility requirements, patients will have outpatient chemotherapy,
cyclophosphamide for two days, fludarabine for five days, for a total of seven days. On the
eighth day, patients will be admitted to the hospital and receive Interleukin-2 and GM-CSF.
On the 22nd day, patients will be admitted to the hospital for a second course of
Interleukin-2. Including a post-treatment evaluation, treatment may last up to 27 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine complete and partial response rate
From first day treatment to response
Marc S Ernstoff, MD
Dartmouth-Hitchcock Medical Center
United States: Food and Drug Administration
|Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756|