Combined Modality Treatment for Patients With Stage IV Melanoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2012

Conditions
Malignant Melanoma Stage IV
Interventions
BIOLOGICAL

DC Vaccine and Cyclophosphamide

"Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10\^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site).~Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks.~CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure."

Trial Locations (1)

75246

Baylor University Medical Center, Dallas

Sponsors
All Listed Sponsors
lead

Baylor Research Institute

OTHER