Purpose of the Vigil® Ovarian Cancer Study - VITAL Study
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 improve patients survival. 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. NCT 02346747
In this study, the sponsor and investigators are assessing:
- the effect on recurrence of cancer after receiving VIGIL® Engineered Autologous Tumor Cells (EATCs) as compared to placebo
- the patient's ability to do everyday tasks and activities after receiving VIGIL® EATCs as compared to placebo.
How Are The Tumor Cells Modified?
When an ovarian cancer patient is enrolled in this study, a piece of their tumor is removed during 'debulking' surgery. 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, Ovarian Cancer (Vigil® EATC-OC).
Who Gets Vigil®
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-OC or placebo.
These Vigil® EATC-OC, standardized to a dose of 10 million cells per milliliter, are frozen and shipped to the clinical trial site, where the dose is administered to the patient.
Tissue Collection Exclusion Criteria
Tissue Collection Inclusion Criteria
- Histologically confirmed papillary serous adenocarcinoma
- Medical condition requiring chronic systemic immunosuppressive therapy (steroid or other)
- Prior splenectomy
- Congestive heart failure, unstable angina, atrial arrhythmia, or cardiovascular disease (current or within the past 6 months)
- History of brain metastases
- Known HIV or chronic Hepatitis B or C infection
- Prior solid organ or bone marrow transplant
- History of active autoimmune disease
- Presumptive Stage III/IV high-grade serous/endometrioid ovarian, fallopian tube or primary peritoneal cancer
- No chemotherapy or investigational agents prior to tissue acquisition for Vigil™ manufacture
- 18 yrs of age or older
- No other malignancy
- ECOG performance status 0-2
- Expected availability of a eligible cumulative mass of ~10-30 grams tissue (cumulative "golf-ball" size mass) for manufacture of immunotherapy
Cost to Patients
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.
Investigators Enrolling Patients In the Study
(Site information will be updated as soon as permissions are received. Meanwhile, please contact Gradalis, Inc., directly through our Contacts page to receive information about those sites).