Tecemotide (L-BLP25) in Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

October 24, 2011

Primary Completion Date

November 25, 2016

Study Completion Date

November 25, 2016

Conditions
Prostate Cancer
Interventions
RADIATION

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.

DRUG

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.

DRUG

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).

DRUG

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.

Trial Locations (1)

Unknown

Please Contact US Medical Information, Rockland

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

EMD Serono

INDUSTRY

NCT01496131 - Tecemotide (L-BLP25) in Prostate Cancer | Biotech Hunter | Biotech Hunter