A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

February 10, 2016

Primary Completion Date

November 12, 2018

Study Completion Date

December 23, 2020

Conditions
Ewing's Sarcoma
Interventions
BIOLOGICAL

Vigil

Vigil 1.0 x 10e7 cells/injection, minimum of 4 to a maximum of 12 administrations.

DRUG

Temozolomide

oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle)

DRUG

Irinotecan

irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously

DRUG

Gemcitabine

675 mg/m2 IV at a rate of 10 mg/m2/min on Day 1 and Day 8 every 21 days

DRUG

Docetaxel

75 mg/m2 IV administered on Day 8 and every 21 days

Trial Locations (6)

10065

Memorial Sloan Kettering Cancer Center, New York

33155

Nicklaus Children's Hospital (Miami Children's Health System), Miami

44195

Cleveland Clinic Children's, Cleveland

72202

Arkansas Children's Hospital, Little Rock

75230

Mary Crowley Cancer Research Centers, Dallas

TOPA - Medical City Dallas Pediatric Hematology-Oncology, Dallas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gradalis, Inc.

INDUSTRY