28
Participants
Start Date
October 24, 2011
Primary Completion Date
November 25, 2016
Study Completion Date
November 25, 2016
Radiation therapy
Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.
Goserelin
ADT (Goserelin) will be administered at a dose of 10.8 milligrams (mg) subcutaneously every 3 months for 24 months for the high risk group and for 6 months in the intermediate risk group, starting 2-3 months prior to radiation therapy.
Cyclophosphamide
Cyclophosphamide will be administered at a single dose of 300 milligrams per square meter (mg/m\^2) to a maximum of 600 mg, as an intravenous injection 3 days prior to the first administration of tecemotide (L-BLP25).
Tecemotide (L-BLP25)
Tecemotide (L-BLP25) will be administered at a dose of 918 microgram (mcg) as subcutaneous injection every 2 weeks for 5 doses followed by every 6 weeks for an additional 4 doses, starting 2-3 months prior to radiation therapy and on the same day that ADT began.
Please Contact US Medical Information, Rockland
Lead Sponsor
National Cancer Institute (NCI)
NIH
EMD Serono
INDUSTRY