Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, H… (NCT02780401) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
United States32 participantsStarted 2016-09-02
Plain-language summary
This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER2 negative is defined as
* 0-1+ HER2 expression by immunohistochemistry (IHC) OR
* Fluorescence in situ hybridization (FISH) negative OR
* HER2 2+ and FISH negative
* Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy administered during the study are eligible and may continue throughout duration of study
* Patients must be at least 28 days post systemic steroids prior to enrollment
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 2
* White blood cell (WBC) \>= 3000/mm\^3
* Hemoglobin (Hgb) \>= 10 g/dl
* Lymphocyte count \>= 800/mm\^3
* Platelet count \>= 75,000/mm\^3
* Serum creatinine =\< 2.0 mg/dl or creatinine clearance \> 60 ml/min
* Total bilirubin =\< 1.5 mg/dl
* Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) =\< 2 times upper limit of normal (ULN)
* Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
* The effects of WOKVAC on the developing human fetus are unknown. Fo…
What they're measuring
1
Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0