NCT01973322View on ClinicalTrials.gov

"Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumor Lysate or Homogenate Combined With Immunomodulating Radiotherapy and/or Preleukapheresis IFN-alfa in Patients With Metastatic Melanoma: a Randomized Proof-of-principle Phase II Study"

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

October 8, 2013

Primary Completion Date

September 30, 2023

Study Completion Date

June 20, 2024

Conditions
Malignant Melanoma of Skin Stage IIIMalignant Melanoma of Skin Stage IV
Interventions
OTHER

arm 1: DC Vaccine + RT

three daily doses of 8 Gy up to 12 Gy delivered to one non-index metastatic field between vaccine doses 1 and 2 (optional to one additional field between vaccine doses 7 and 8) utilizing IMRT-IMAT techniques

OTHER

arm 2: DC Vaccine + IFN-alfa

daily 3 MU subcutaneous IFN-alfa for 7 days before leukapheresis (day -15 to -9, and for 7 days before any other additional leukapheresis)

OTHER

arm 3: both arm 1 and 2 + RT

both 1 and 2 external immunostimulant conditions (Intradermal Autologous Dendritic Cell Vaccine + 3 single boosts of RT + IFN-alfa, 3 MU daily for 7 days before leukapheresis)

BIOLOGICAL

arm 4: DC Vaccine

neither 1 or 2 external immunostimulant conditions (only Intradermal Autologous Dendritic Cell Vaccine)

Trial Locations (1)

47014

UO Immunoterapia e laboratorio TCS, IRST IRCCS, Meldola

All Listed Sponsors
lead

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

NCT01973322 - "Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumor Lysate or Homogenate Combined With Immunomodulating Radiotherapy and/or Preleukapheresis IFN-alfa in Patients With Metastatic Melanoma: a Randomized Proof-of-principle Phase II Study" | Biotech Hunter | Biotech Hunter