High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma
- Determine the objective response rate in lymphodepleted patients with metastatic
melanoma treated with cyclophosphamide, fludarabine, and high-dose interleukin-2.
- Determine the feasibility of this regimen in these patients.
- Determine the quality and quantity of lymphocyte recovery in these patients during and
after treatment with this regimen.
- Determine time to disease progression and survival in patients treated with this
OUTLINE: This is an open-label, multicenter study.
Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days
1 and 2 and fludarabine IV over 30 minutes on days 3-7. Patients then receive high-dose
interleukin-2 IV every 8 hours (14 doses) on days 8-12 and 22-26. Patients also receive
sargramostim (GM-CSF) subcutaneously beginning on day 8 and continuing until blood counts
recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST
Objective response as measured by radiological and physical examination using RECIST criteria.
Response at 12 weeks
Marc S. Ernstoff, MD
Norris Cotton Cancer Center
United States: Federal Government
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|