Vigil® Clinical Trial in Ewing's Sarcoma
This clinical trial is designed to evaluate whether a tumor cell that is engineered to make it more recognizable by our body’s immune system, can generate an immune response from our body such that it keeps the cancer in check and improves patient survival.
More specifically, the purpose of this study is to evaluate the safety of Vigil® Engineered Autologous Tumor Cells (EATCs) as compared to chemotherapy in patients with Ewing’s Sarcoma. In this study, the sponsor and investigators are assessing:
- safety and efficacy of Vigil® EATCs as compared to chemotherapy, Gemcitabine and Docetaxel
- how the VIGIL® EATC immunotherapy and the chemotherapy affect the immune system
Who Gets the Vigil® EATCs?
This clinical trial is a 1:1 randomized clinical trial, with two arms, the test arm, Arm A, and the “control” arm, Arm B. Each patient that is enrolled in the clinical trial is randomly assigned to either Arm A or Arm B. “1:1 randomization” means that each patient has an equal chance of receiving either Vigil® EATC or chemotherapy.
Cost to the Patient
Subjects will not be charged for participating in this clinical trial. Subjects will discuss any other costs associated with the clinical trial with their physician.
How Are The Tumor Cells Modified?
A patient enrolled in this study needs to undergo surgery to remove a piece of their tumor. This tumor is shipped to Gradalis, Inc.’s manufacturing facility, where cells derived from the tumor are genetically modified using Vigil® technology, to make them more recognizable to the patient’s immune system. After steps of transforming and irradiation, the tumor cells are then called Vigil Engineered Autologous Tumor Cells, Ewing’s Sarcoma (Vigil® EATC-EWS).
These Vigil® EATC-EWS, standardized to a dose of 10 million cells per milliliter, are then frozen and shipped to the clinical trial site, where the dose is administered to the patient.
Clinical trials involve research to identify the risks and benefits of investigational therapies. Participation in this study may or may not make your health better, and there may be risks associated with participation. However, information from this study will help doctors learn more about Vigil® EATC as a potential treatment for cancer, and this information could help future cancer patients. Patients who participate in this study will be provided medical care during the course of this study, under a physician’s supervision.
Patients who wish to participate in this clinical trial need to meet both Tissue Collection, and Study Entry Inclusion and Exclusion Criteria. This is not an exhaustive list. Additional details about the criteria may be found on the clinicaltrials.gov website. Trial no. NCT02511132
Tissue Collection Entry Criteria
- Histologically confirmed Ewing's Sarcoma
- ≥ 2 years of age
- Estimated survival ≥ 6 months
- Evidence of EWS translocation
- Metastatic disease
- Refractory or intolerant to ≥ 2 lines of systemic chemotherapy.
- Expected availability of a eligible cumulative mass of ~10-30 grams tissue ("golf-ball" size) or pleural fluid estimated volume ≥ 500mL for manufacture of immunotherapy
Tissue Collection Exclusion Criteria
- Medical condition requiring chronic systemic immunosuppressive therapy (steroid or other)
- Known history of other malignancy
- Brain metastases unless treated with curative intent and without evidence of progression for ≥ 2 months.
- History of autoimmune disease
- History of allergies or sensitivities to gentamicin
- Known hypersensitivity to docetaxel
Investigators Enrolling Patients in This Clinical Trials
Investigators Enrolling Patients (Additional sites enrolling in the study will be added soon. Please contact Gradalis, Inc., to receive information about other sites where study is open.)
St. Louis: Dr. Brian Van Tine, Washington University School of Medicine, P: 314-747-9488 E: email@example.com
Bronx: Dr. Jonathan Gill, Children's Hospital at Montefiore, P: 718-741-2342 E:
Cleveland: Dr. Peter Anderson, Cleveland Clinic Foundation-Children's, P: 216-445-4044 E: firstname.lastname@example.org Cleveland: Dr. Stacey Zahler, Cleveland Clinic Foundation-Children's, P: 216-445-3588 E: email@example.com
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