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

Conditions

SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose) — DRUG
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 — DRUG
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 — DRUG
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 — DRUG
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.

The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment for recurrent glioblastoma multiform (GBM).

Experimental: SL-701 + GM-CSF + Imiquimod
Participants will receive SL-701 with the vaccine adjuvants granulocyte macrophage-colony stimulating factor (GM-CSF) injection and imiquimod topical cream. A complete dose of study drug consists of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site is repeated at 24 hours after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) will be administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes of SL-701 emulsion injection) to the SL-701 emulsion injection site. In addition to the SL-701 emulsion injection, the participant will receive a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion. An additional dose of imiquimod cream will be applied at the same site by the participant 24 hours later.
Experimental: SL-701; poly-ICLC 1.6 mg; bevacizumab
SL-701 emulsion and the adjuvant poly-ICLC will be administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab will be administered every 2 weeks, subsequent to the administration of SL-701/poly-ICLC.

Number of Participants Experiencing Regimen-limiting Toxicity (RLT) [ Time Frame: Approximately 24 weeks ]

Facility	City	State	ZIP	Site coordinators
University of Alabama	Birmingham	Alabama	35294	-
Barrow Neurological Institute	Phoenix	Arizona	85013	-
Center for Neurosciences	Tucson	Arizona	85718	-
Cedars Sinai Medical Center	Los Angeles	California	90048	-
George Washington University	Washington D.C.	District of Columbia	20052	-
University of Florida	Gainesville	Florida	32611	-
Piedmont Cancer Institute	Atlanta	Georgia	30309	-
Northwestern University	Chicago	Illinois	60208	-
Dana Farber Cancer Institute	Boston	Massachusetts	02115	-
Henry Ford Health System	Detroit	Michigan	48202	-
Columbia University Medical Center	New York	New York	10027	-
Cleveland Clinic	Cleveland	Ohio	44195	-
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15260	-
Rhode Island Hospital	Providence	Rhode Island	02903	-
Baylor Charles A Sammons Cancer Center	Dallas	Texas	75246	-
University of Virginia	Charlottesville	Virginia	22908	-

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