NCT00559026View on ClinicalTrials.gov

Phase I/II Study of Chemo-Immunotherapy Combination in Melanoma Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 30, 2004

Study Completion Date

September 30, 2006

Conditions
Melanoma
Interventions
BIOLOGICAL

Melan-A

i.d. injections of Melan-A: 26-35 (A27L) and gp100: 209-217 (210M) peptides (250 µg each) formulated in Montanide ISA-51 plus s.c. injection of 3MU IFN-α, as an adjuvant on day 1 and 8 every 21 days for a total of 5 courses

OTHER

Melan-A plus Dacarbazine

Dacarbazine plus vaccine: the vaccination schedule as in arm 1 was combined with DTIC (800 mg/mq i.v.) administered one day before each vaccine administration according to the standard treatment.

Trial Locations (2)

00133

University Hospital Tor Vergata, Rome

00153

Regina Elena Cancer Institute, Rome

All Listed Sponsors
collaborator

Regina Elena Cancer Institute

OTHER

collaborator

University of Rome Tor Vergata

OTHER

lead

Istituto Superiore di Sanità

OTHER

NCT00559026 - Phase I/II Study of Chemo-Immunotherapy Combination in Melanoma Patients | Biotech Hunter | Biotech Hunter