DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Kidney Cancer
Interventions
BIOLOGICAL

Aldesleukin,

Recombinant human interleukin-2 (Proleukin, Chiron Therapeutics) will be administered as a five day (120 hr) continuous intravenous infusion at a dose of 18x106 IU per square meter of body surface area per day as per the Negrier regimen (21). The treatment schedule consists of two induction cycles and three maintenance cycles. Each induction cycle consists of two five-day courses of interleukin-2 infusion separated by a nine-day break. Each maintenance cycle consists of a five-day infusion followed by 23-day rest period of no therapy.

BIOLOGICAL

autologous tumor cell vaccine

we will administer 1 X 107 DC cells. The autologous tumor cell vaccine (1 X 107 cells/1cc) in lactated ringers solution and injected into one (or two if clinically necessary) inguinal lymph nodes under ultrasound guidance. Each cycle of DC vaccine will be administered alternately in the right and left inguinal lymph nodes.

BIOLOGICAL

recombinant interferon alfa

Recombinant human interferon alfa-2a (Roferon, Roche), at a dose of 6 million IU per day three times a week subcutaneously will be given during the two interleukin-2 induction cycles and during each interleukin-2 maintenance cycle

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

NCT00085436 - DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC | Biotech Hunter | Biotech Hunter