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Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer

Breast Ductal Carcinoma In Situ Clinical Trial

Official title:
VADIS Trial: Phase II Trial of Nelipeimut-S Peptide Vaccine in Women With DCIS of the Breast

Clinical Trial Summary

This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Evaluate for nelipepimut-S-specific cytotoxic T lymphocyte (CTL; cluster of differentiation [CD]8+ T cell) response in patients receiving NeuVax (nelipepimut-S plus GM-CSF [sargramostim]) compared to patients receiving GM-CSF alone (control). SECONDARY OBJECTIVES: I. Toxicity profile and frequency of adverse events in women with ductal carcinoma in situ (DCIS) of the breast receiving nelipepimut-S vaccine as compared to women receiving GM-CSF alone. II. Presence of DCIS at resection. III. Difference in HER2 expression in the biopsy and the surgical specimen excised post-vaccination. IV. Histologic responses: IVa. Degree of lymphocyte infiltration determined on hematoxylin and eosin (H&E) stained slides and immune infiltration as determined by multiplex immunofluorescence staining for markers including but not limited to CD3, CD4 and CD8. IVb. Immune infiltrates in normal tissue maximally distant from the tumor (in mastectomy samples). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive nelipepimut-S plus GM-CSF vaccine intradermally (ID) on days 0 and 14 and then undergo surgery on day 28. ARM II: Patients receive sargramostim ID on days 0 and 14 and then undergo surgery on day 28. After completion of study treatment, patients are followed up at 1 and 3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02636582
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date June 14, 2016
Completion date May 17, 2023
View Details
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