Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Melanoma (Skin)
Interventions
BIOLOGICAL

aldesleukin

high dose: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days (maximum 5 doses) or low dose: 250,000 IU/kg subcutaneously daily for 5 days, after a two day rest, 125,000 IU/kg subcutaneously daily for 5 days for five weeks (2 days rest per week)

BIOLOGICAL

filgrastim

10 mcg/kg/day daily subcutaneously until neutrophil count \>1x10\^9/1.

BIOLOGICAL

therapeutic tumor infiltrating lymphocytes

Lymphocytes that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

DRUG

cyclophosphamide

60 mg/kg/day x 2 days intravenously over 1 hour

DRUG

fludarabine phosphate

25 mg/m\^2/day intravenous piggyback daily over 15-20 minutes for 5 days

RADIATION

radiation therapy

Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

Trial Locations (2)

20892-1182

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office, Bethesda

20892-1201

NCI - Surgery Branch, Bethesda

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

National Institutes of Health Clinical Center (CC)

NIH

NCT00096382 - Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma | Biotech Hunter | Biotech Hunter