NCT00085423View on ClinicalTrials.gov

Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 29, 2004

Primary Completion Date

December 31, 2008

Study Completion Date

February 28, 2010

Conditions
Melanoma (Skin)
Interventions
BIOLOGICAL

aldesleukin

‡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

BIOLOGICAL

sargramostim

GM-CSF was given subcutaneously daily from day 8 until absolute granulocyte count exceeds 5,000 cells/mL for 2 consecutive days.

DRUG

cyclophosphamide

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.

DRUG

fludarabine phosphate

Fludarabine IV (25 mg/M2/day)-five daily doses from Day 3

Trial Locations (1)

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Dartmouth-Hitchcock Medical Center

OTHER

NCT00085423 - Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma | Biotech Hunter | Biotech Hunter