Disease: Ductal Carcinoma in Situ (DCIS)
Trial Design: Phase 2
VADIS: Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast.
A Phase 2 trial clinical with NeuVax as a single agent in patients with ductal carcinoma in situ, or DCIS, is open for enrollment. The trial is potentially positions NeuVax as a treatment for earlier stage disease. The trial has an immunological endpoint evaluating NeuVax peptide-speciﬁc cytotoxic T lymphocyte (CTL; CD8+ T-cell) response in vaccinated patients. DCIS is deﬁned by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct, and.the abnormal cells have not spread outside the duct to other tissues in the breast. DCIS is the most common type of breast cancer. In some cases, DCIS may become invasive cancer and spread to other tissues, and at this time, there is no way to know which lesions could become invasive.
This trial is being run in collaboration with the National Cancer Institute (NCI). The University of Texas M.D. Anderson Cancer Center (MDACC) Phase I and II Chemoprevention Consortium is the lead for this multi-center trial. The Consortium is funded through the Division of Cancer Prevention at NCI, which will provide financial and administrative support for the trial. Galena will provide NeuVax, as well as additional financial and administrative support.
The NCI’s Division of Cancer Prevention (DCP) conducts and supports research to determine a person’s risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer. With an overall goal to detect such changes and intervene early in the cancer process to prevent symptomatic disease and death, DCP funds and provides administrative support to clinical and laboratory researchers, community and multidisciplinary teams, and collaborative scientific networks.
Trial Design and Eligibility
ClinicalTrials.gov: Identifier NCT02636582
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About the disease
Ductal Carcinoma in Situ (DUK-tul KAR-sih-NOH-muh in SY-too), or DCIS, is defined by the National Cancer Institute as a noninvasive condition in which abnormal cells are found in the lining of a breast duct, and is the most common type of breast cancer. The abnormal cells have not spread outside the duct to other tissues in the breast. In some cases, DCIS may become invasive cancer and spread to other tissues, and at this time, there is no way to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. According to the American Cancer Society, in 2015 there are estimated to be over 60,000 new cases of ductal carcinoma in situ.