Do not make unauthorized copies. Subjects should be provided with full supportive care measures, as clinically indicated, and in accordance with institutional standards. Such care includes medication for pain control and symptom management, antibiotics, bisphosphonates, antiemetics, colony stimulating factors, and transfusions of blood or blood products. Prophylactic GCSF is allowed for both treatment arms, if indicated. Treatment for drug-related adverse events should be administered at the discretion of the investigator. Peg-filgrastim may be administered after completion of Day 5 temozolomide to facilitate ANC recovery. 8.6 Contraception Female subjects of childbearing potential must consent to use a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) throughout the study period and for 28 days after their final autologous Vigil administration. A method of contraception must be employed by all subjects (male and female). 8.7 Toxicity Toxicities will be graded and reported according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) Version 5. This document can also be downloaded from the Cancer Therapy Evaluation Program (CTEP) home page <http://ctep.cancer.gov>. Adverse events will be summarized using the MedDRA coding system or higher. The NCI- CTCAE will be used for AE grading. All AEs, regardless of severity, will be followed by the Treating Physician until resolution is satisfactory. 9.0 SCHEDULE OF ASSESSME NTS Pre-study Assessments / Surgery Pre-Screening The following evaluations will be performed within 4 weeks of tumor procurement (unless otherwise specified): 1. A signed Informed Consent Form for tissue harvest must be obtained. 2. It has been confirmed that the subject meets all tissue procurement inclusion criteria and none of the exclusion criteria. 3. A complete medical history must be obtained. 4. A physical examination must be obtained. Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 50 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document.