Melanoma (Skin) Clinical Trial
Official title:
High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in
different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2
may stimulate a person's white blood cells to kill tumor cells and may help a person's
immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine
together with high-dose interleukin-2 works in treating patients with metastatic melanoma.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
regimen.
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
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