Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

April 13, 2012

Primary Completion Date

April 9, 2016

Study Completion Date

August 1, 2016

Conditions
Cervical CancerOropharyngeal CancerVaginal CancerAnal CancerPenile Cancer
Interventions
DRUG

Fludarabine

Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.

BIOLOGICAL

Young TIL

Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).

DRUG

Aldesleukin

Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT01585428 - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers | Biotech Hunter | Biotech Hunter