At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic melanoma with measurable disease
- ✓Age >18 years
- ✓Karnofsky performance status 60-100%
- ✓Life expectancy at least 12 weeks
- ✕History of brain metastases
- ✕Uncontrolled diabetes
- ✕History of autoimmune disease
- ✕Active infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating aldesleukin, sargramostim, and 2 other interventions for Melanoma (Skin). Completed, enrolled 20 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
‡Interleukin-2 (aldesleukin) IV (600,000 U/kg; Chiron, Emeryville, CA): two 5-day courses on days 8 and 22. Interleukin-2 was given over 15 minutes every 8 hours. Goal is 14 doses/5-day course
GM-CSF was given subcutaneously daily from day 8 until absolute granulocyte count exceeds 5,000 cells/mL for 2 consecutive days.
Cyclophosphamide (60 mg/kg/d; Baxter, Deerfield, IL) intravenously (IV) for 2 days with sodium 2- mercaptoethanesulfonate (Mesna; Sicor, Irvine, CA) at 20% of cyclophosphamide dose IV 15 minutes before and 40% of the cyclophosphamide dose orally at 2 and 6 hours after the initiation of chemotherapy.
Fludarabine IV (25 mg/M2/day)-five daily doses from Day 3