Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

September 1, 2017

Study Completion Date

January 22, 2018

Conditions
Adult Brain GlioblastomaGlioblastoma Multiforme
Interventions
DRUG

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)."

DRUG

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.

DRUG

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."

DRUG

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.

Trial Locations (16)

10027

Columbia University Medical Center, New York

15260

University of Pittsburgh Medical Center, Pittsburgh

20052

George Washington University, Washington D.C.

22908

University of Virginia, Charlottesville

30309

Piedmont Cancer Institute, Atlanta

32611

University of Florida, Gainesville

35294

University of Alabama, Birmingham

44195

Cleveland Clinic, Cleveland

48202

Henry Ford Health System, Detroit

60208

Northwestern University, Chicago

75246

Baylor Charles A Sammons Cancer Center, Dallas

85013

Barrow Neurological Institute, Phoenix

85718

Center for Neurosciences, Tucson

90048

Cedars Sinai Medical Center, Los Angeles

02115

Dana Farber Cancer Institute, Boston

02903

Rhode Island Hospital, Providence

All Listed Sponsors
lead

Stemline Therapeutics, Inc.

INDUSTRY

NCT02078648 - Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme | Biotech Hunter | Biotech Hunter