Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma

Ovarian Cancer Clinical Trial

Official title: A Phase I Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma

Status Terminated

Clinical Trial Summary

This is a Phase I trial to test the safety and feasibility of OncoImmunome vaccine in stage III/IV ovarian cancer patients. OncoImmunome is a tumor specific vaccine formulation which is predicted to elicit tumor-protective immune responses. A total of 15 patients will be enrolled from the Principal Investigator (PI) clinical practice. These patients will have just successfully completed standard of care surgical debulking with preservation of fresh tumor, chemotherapy treatment and be in documented clinical remission prior to receiving the vaccine. The patients receive 6-monthly doses of the vaccine and are monitored for up to 5 years post vaccination. This is a personalized vaccine, unique to each patient and is the "first in human" use.

Clinical Trial Description

The study will be conducted under an IRB approval, in accordance with FDA regulations and Human Subject Protection regulations. Female patients will undergo standard of care therapy to include exploratory laparotomy and cytoreduction (debulking) surgery followed by chemotherapy. Only patients with histological confirmation of FIGO Stage III/IV epithelial adenocarcinoma of ovarian, tubal or peritoneal origin will be screened and enrolled into the study. At cytoreduction surgery a portion of the surgically resected tumor is preserved for vaccine production. The surgically resected tumor as well as normal cells obtained from peripheral blood shall be used for extraction of RNA and DNA sequencing of the tumor and normal transcriptomes, as well as normal exome sequencing, in the Genomic Core Facility at UConn Health. Patient's blood cells shall also be HLA typed.

When the patient has recovered from surgery, standard of care chemotherapy is given. Following completion of standard chemotherapy (6-8 cycles) and Investigator's confirmation of clinical remission, patients will be consented as subjects for the experimental investigative portion of the study.

The overall purpose of this research study is to produce and test the safety of a new experimental vaccine called OncoImmunome in people with Stage III/IV Ovarian Cancer. An "experimental vaccine" is a vaccine that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). The study has been divided into two parts: 1)Tumor Tissue and Blood Sample Collection and 2) Vaccine and Follow-up.

Study participants will consent to the following:

1. Tumor Tissue and Blood Sample Collection: The purpose of this part of the study is to collect participants' blood and tumor tissue and test it for genetic mutations. These test results will be used to manufacture a study vaccine that is unique to the participant and to their ovarian cancer.

2. Vaccine and Follow-up: The purpose of this part of the study is to test the safety of the experimental drug (vaccine) called OncoImmunome, which has been produced specifically for each participant.

Subject participation in this research study will last up to 5 years. The vaccine will be produced over a 6 month period, and for six months subjects will receive the study vaccine (1 study vaccine dose per month or 6 study vaccine doses total). However, the researchers will continue to collect all subjects information for up 5 years from the time they provided their tumor sample and blood for the research. ;

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT02933073
• Study type: Interventional
• Source: UConn Health
• Status: Terminated
• Phase: Phase 1
• Start date: November 2016
• Completion date: August 2022