Multiple Antigen-Engineered DC Vaccine for Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

May 31, 2016

Study Completion Date

August 31, 2017

Conditions
Melanoma
Interventions
BIOLOGICAL

DC Vaccine + IFN

"Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection, or lower dose per sponsor's discretion.~IFN: 20 MU/m²/d (rounded to the nearest 1.0 million unit) administered IV x 5 consecutive days out of 7 (M-F) every week x 4 weeks."

BIOLOGICAL

AdVTMM2/DC Vaccination

Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection.If cell counts are below the target, as few as 5x10e6 AdVTMM2/DC may be administered. However, at the discretion of the sponsor and/or the treating physician, a lower dose of DC that fulfills all of the other criteria for release may be administered on a case by case basis. If this occurs a dose exception form will be completed by the IMCPL, signed by the treating physician and filed in the subjects research records.

Trial Locations (1)

15232

University of Pittsburgh Cancer Institute, Pittsburgh

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Lisa H. Butterfield, Ph.D.

OTHER

NCT01622933 - Multiple Antigen-Engineered DC Vaccine for Melanoma | Biotech Hunter | Biotech Hunter