Trial of Vigil for Patients with Ovarian Cancer
Sponsor: Gradalis, Inc.
ClinicalTrials ID:NCT02346747
This study is testing a new treatment called Vigil for women with ovarian, fallopian tube, or primary peritoneal cancer. It aims to find out if Vigil can help delay the return of cancer compared to a placebo.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this clinical trial is to see if a new treatment called Vigil can help women with certain types of ovarian cancer by delaying the return of the disease. Participants will be randomly assigned to receive either Vigil or a placebo (a substance with no active treatment) after their initial surgery and chemotherapy. The study will monitor how long it takes for the cancer to come back in those who receive Vigil compared to those who do not.
Description
This study involves women with advanced ovarian, fallopian tube, or primary peritoneal cancer who have already had surgery and chemotherapy. The trial is designed to test a new treatment called Vigil, which is made from the patient's own tumor cells. Participants will be randomly divided into two groups: one will receive Vigil, and the other will receive a placebo. The treatment is given as an injection under the skin once a month for up to six months.
Participants will be monitored regularly with scans and tests to check for any signs of cancer returning. The study will last for several years, with follow-up visits to track the participants' health and any additional treatments they may receive. The goal is to see if Vigil can help keep the cancer from coming back longer than the placebo.
Eligibility Criteria
Inclusion Criteria
- Women with advanced ovarian, fallopian tube, or primary peritoneal cancer.
- Completed surgery and chemotherapy with no signs of cancer remaining.
- Able to start the study treatment within 3 to 8 weeks after finishing chemotherapy.
- Have at least four doses of Vigil successfully made from their tumor cells.
- In good overall health with normal blood counts and organ function.
- Willing to sign a consent form and follow study procedures.
Exclusion Criteria
- Recent surgery, radiation, or experimental treatments within 4 weeks before starting the study.
- Cancer involving the uterus or certain other areas.
- Taking medications that suppress the immune system.
- Serious heart conditions or recent heart attacks.
- Mental health issues that could affect participation.
- History of brain cancer spread.
- Infections like HIV or hepatitis.
- Previous organ or bone marrow transplants.
- Autoimmune diseases, except for well-controlled diabetes or vitiligo.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | 36604 | Mobile | Alabama |
| Southern California Permanente Medical Group | 92618 | Irvine | California |
| Palo Alto Foundation Medical Group | 94115 | San Francisco | California |
| University Of Miami Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Florida Cancer Specialists | 33401 | West Palm Beach | Florida |
| Georgia Cancer Center at Augusta University | 30912 | Augusta | Georgia |
| University Of Kentucky Markey Cancer Center | 40536 | Lexington | Kentucky |
| Maine Medical Center: MMP Women's Health | 04074 | Scarborough | Maine |
| Dana Farber Cancer Institute: Gynecologic Oncology | 02215 | Boston | Massachusetts |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.