Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

August 31, 2010

Study Completion Date

October 31, 2010

Conditions
Melanoma (Skin)
Interventions
BIOLOGICAL

MART-1:27-35 peptide vaccine

BIOLOGICAL

aldesleukin

BIOLOGICAL

filgrastim

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

therapeutic autologous lymphocytes

BIOLOGICAL

therapeutic tumor infiltrating lymphocytes

DRUG

cyclophosphamide

DRUG

fludarabine phosphate

PROCEDURE

autologous hematopoietic stem cell transplantation

PROCEDURE

in vitro-treated peripheral blood stem cell transplantation

RADIATION

total-body irradiation

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

NCT00091104 - Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma | Biotech Hunter | Biotech Hunter