74
Participants
Start Date
May 31, 2014
Primary Completion Date
September 1, 2017
Study Completion Date
January 22, 2018
SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose)
"1.0 mL injection taken from 0.7 mL of SL-701 mixed at a 1:1 (v/v) ratio with 0.7 mL of Montanide. Preferred site of SC injection is in the right or left upper arms.~Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC should be administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated)."
Bevacizumab
Following the administration of SL-701 and poly-ICLC, bevacizumab will be administered IV at a dose of 10 mg/kg. Bevacizumab infusions may occur over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
SL-701 + GM-CSF
"1.0 mL injection taken from 0.7 mL of SL-701 mixed at a 1:1 (v/v) ratio with 0.7 mL of Montanide. Preferred site of SC injection is in the right or left upper arms.~150 μg GM-CSF should be administered as a SC injection immediately after SL-701 emulsion administration and within 1 cm from the center of the SL-701 emulsion injection site."
Imiquimod
Within 5 minutes following the administration of the SL-701 emulsion, approximately 125 mg of imiquimod cream will be applied topically on the injection site. The imiquimod cream should be rubbed in until the cream is no longer visible.
Columbia University Medical Center, New York
University of Pittsburgh Medical Center, Pittsburgh
George Washington University, Washington D.C.
University of Virginia, Charlottesville
Piedmont Cancer Institute, Atlanta
University of Florida, Gainesville
University of Alabama, Birmingham
Cleveland Clinic, Cleveland
Henry Ford Health System, Detroit
Northwestern University, Chicago
Baylor Charles A Sammons Cancer Center, Dallas
Barrow Neurological Institute, Phoenix
Center for Neurosciences, Tucson
Cedars Sinai Medical Center, Los Angeles
Dana Farber Cancer Institute, Boston
Rhode Island Hospital, Providence
Stemline Therapeutics, Inc.
INDUSTRY