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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02636582
Recruitment Status : Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE December 18, 2015
First Posted Date  ICMJE December 22, 2015
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE June 14, 2016
Actual Primary Completion Date June 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Change in the number of nelipepimut-S-cytotoxic T lymphocytes (CTL), detected using a dextramer assay [ Time Frame: Pre-vaccination to up to 1 month after surgery ]
Change of nelipepimut-S-specific CTL at the 1 month (+/- 7 days) after completion of the vaccination series timepoint from baseline will be estimated for each group using mean, standard deviation, median, minimum and maximum. Two-sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare the change between the two groups. Nelipepimut-S-specific CTL will also be measured repeatedly through 6 months after the last vaccination. Repeated measures analysis including mixed effects model will be performed to analyze the effect of treatment on nelipepimut-S-specific CTL change over time.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
Change in the number of nelipepimut-S-cytotoxic T lymphocytes (CTL), detected using a dextramer assay [ Time Frame: Pre-vaccination to up to 1 month after completion of the vaccination series timepoint ]
Change of nelipepimut-S-specific CTL at the 1 month (+/- 7 days) after completion of the vaccination series timepoint from baseline will be estimated for each group using mean, standard deviation, median, minimum and maximum. Two-sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare the change between the two groups. Nelipepimut-S-specific CTL will also be measured repeatedly through 6 months after the last vaccination. Repeated measures analysis including mixed effects model will be performed to analyze the effect of treatment on nelipepimut-S-specific CTL ch
Change History Complete list of historical versions of study NCT02636582 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • Toxicity profile according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.03 [ Time Frame: Up to 3 months after surgery ]
    Compared between the two groups. Adverse events by grade and relationship will be summarized by tabulation for each group.
  • Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.03 [ Time Frame: Up to 3 months after surgery ]
    Adverse events by grade and relationship will be summarized by tabulation for each group.
  • In vivo immune response to nelipepimut-S determined by delayed type hypersensitivity reaction [ Time Frame: Up to 1 months after surgery ]
    For each patient, pre- and post-vaccination delayed type hypersensitivity (DTH) measurements will be compared. DTH data will be presented as means +/- standard errors and compared (pre- versus [vs] post-vaccination) using a student t test.
  • Change in the number of epitope specific-cytotoxic T lymphocyte (CTL) [ Time Frame: Pre-vaccination to up to 6 months after surgery at the time of the final study visit ]
    Evidence of inter-antigenic epitope spreading will be evaluated by quantifying the number of CTL specific for the folate binding protein derived epitope E39 (EIWTHSYKV) and the cyclin E-derived epitope CCNE144-152 (ILLDWLMEV). The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/analysis of variance (ANOVA)/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete biomarkers will be tested by chi-square or Fisher's exact test. Paired t-test/Wilcoxon rank sum test and McNemar's test may be used to test the change of a single continuous biomarker and discrete biomarker, respectively, over time within each treatment group.
  • Cytotoxic T lymphocyte (CTL) functional capability, measured using intracellular cytokine assays [ Time Frame: Up to 6 months after completion of the vaccination series timepoint ]
    The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete biomarkers will be tested by chi-square or Fisher's exact test. Paired t-test/Wilcoxon rank sum test and McNemar's test may be used to test the change of a single continuous biomarker and discrete biomarker, respectively, over time within each treatment group.
  • Polyfunctional cytokine responses assessed by multiplex assays [ Time Frame: Up to 6 months after completion of the vaccination series timepoint ]
    A standard curve will be generated for each cytokine and the cytokine concentration in individual patient samples will be determined by comparison to that standard curve. The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete biomarkers will be tested by chi-square or Fisher's exact test. Paired t-test/Wilcoxon rank sum test and McNemar's test may be used to test the change of a single continuous biomarker and discrete biomarker, respectively, over time within each treatment group.
  • Presence of ductal carcinoma in situ (DCIS) at resection [ Time Frame: At surgery ]
    The histologic data will be presented in tabular form to examine whether the vaccine treatment is associated with the absence of DCIS, induction of necrosis, reduction in histologic grade, or a reduction in the size of DCIS. These data will be descriptive only.
  • Difference in HER2 expression in the biopsy and the surgical specimen excised post-vaccination [ Time Frame: Pre-vaccination to up to surgery ]
    HER2 scoring will be determined according to the American Society of Clinical Oncology/College of American Pathologists clinical guidelines. Pre-vaccination and post-vaccination specimens will be compared. The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete biomarkers will be tested by chi-square or Fisher's exact test. Paired t-test/Wilcoxon rank sum test and McNemar's test may be used to test the change of a single continuous biomarker and discrete biomarker, respectively, over time within each treatment group.
  • Degree of lymphocyte infiltration [ Time Frame: Pre-vaccination to up to surgery ]
    Intra-tumoral and stromal tumor infiltrating lymphocytes will be scored as a continuous variable and the percentage of in the surgical specimen will be compared to that in the pre-vaccination diagnostic biopsy. The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. Paired t-test/Wilcoxon rank sum test and McNemar's test may be used to test the change of a single continuous biomarker and discrete biomarker, respectively, over time within each treatment group.
  • Immune infiltration as determined by immunohistochemistry staining for CD3, CD4 and CD8 [ Time Frame: Pre-vaccination to up to surgery ]
    Total number of positive cells for each immune cell marker in 10 high power fields in the DCIS samples from pre-treatment and post-treatment samples will be counted and a "difference statistic" for each participant will be calculated (the change in the total number of marker-positive infiltrating immune cells in the pre- and post-treatment samples for each participant). These biomarker data will be visualized by plotting each participant's pre- and post-treatment value ("spaghetti plots"). The average "difference statistic" will then be calculated for the HER2 vaccine-treated group and the GM-CSF alone-treated group, and the average difference statistic will be compared using both paired and two-sample t-tests to determine effect of the vaccine on DCIS cell proliferation. Statistically significance will be defined as a p-value less than 0.05.
  • Proliferation as measured by Ki67 staining in ductal carcinoma in situ (DCIS) cells [ Time Frame: Pre-vaccination to up to surgery ]
    The % Ki67-positive cells in the DCIS samples from pre-treatment and post-treatment samples and a "difference statistic" for each participant will be calculated (the change in % Ki67 between pre- and post-treatment sample for each participant). If the distribution of % Ki67 values is not a normal distribution, then it may be necessary to log-transform the primary % Ki67 data before calculating the difference statistic. These biomarker data will be visualized by plotting each participant's pre- and post-treatment value ("spaghetti plots"). The average "difference statistic" will then be calculated for the HER2 vaccine-treated group and the GM-CSF alone-treated group, and the average difference statistic will be compared using both paired and two-sample t-tests to determine effect of the vaccine on DCIS cell proliferation. Statistical significance will be defined as a p-value less than 0.05.
  • Apoptosis as measured by cleaved caspase 3 in ductal carcinoma in situ (DCIS) cells [ Time Frame: Pre-vaccination to up to surgery ]
    The % positive cells in the DCIS samples from pre-treatment and post-treatment samples and a "difference statistic" for each participant will be calculated (the change in % positive between pre- and post-treatment sample for each participant). If the distribution of % positive values is not a normal distribution, then it may be necessary to log-transform the primary data before calculating the difference statistic. These biomarker data will be visualized by plotting each participant's pre- and post-treatment value ("spaghetti plots"). The average "difference statistic" will then be calculated for the HER2 vaccine-treated group and the GM-CSF alone-treated group, and the average difference statistic will be compared using both paired and two-sample t-tests to determine effect of the vaccine on DCIS cell proliferation. Statistical significance will be defined as a p-value less than 0.05.
  • Immune infiltrates in normal tissue maximally distant from the tumor (in mastectomy samples) [ Time Frame: At surgery ]
    The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete biomarkers will be tested by chi-square or Fisher's exact test. Paired t-test/Wilcoxon rank sum test and McNemar's test may be used to test the change of a single continuous biomarker and discrete biomarker, respectively, over time within each treatment group. Repeated measures analysis including mixed effects model will be performed to analyze the effect of treatment on biomarkers change over time.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • Apoptosis as measured by cleaved caspase 3 in DCIS cells [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    The % positive cells in the DCIS samples from pre-treatment and post-treatment samples and a "difference statistic" for each participant will be calculated (the change in % positive between pre- and post-treatment sample for each participant). If the distribution of % positive values is not a normal distribution, then it may be necessary to log-transform the primary data before calculating the difference statistic. These biomarker data will be visualized by plotting each participant's pre- and post-treatment value ("spaghetti plots"). The average "difference statistic" will then be calculated
  • Change in the number of epitope specific-CTL [ Time Frame: Pre-vaccination to up to 9 months after surgery at the time of the final study visit ]
    Evidence of inter-antigenic epitope spreading will be evaluated by quantifying the number of CTL specific for the folate binding protein derived epitope E39 (EIWTHSYKV) and the cyclin E-derived epitope CCNE144-152 (ILLDWLMEV). The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/analysis of variance (ANOVA)/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will
  • CTL functional capability, measured using intracellular cytokine assays [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete biomarkers will be tested by chi-square or Fisher's exact test. Paired t-test/Wilcoxon rank sum test and McNemar's test may be used to test the change
  • Degree of lymphocyte infiltration [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    Intra-tumoral and stromal tumor infiltrating lymphocytes will be scored as a continuous variable and the percentage of in the surgical specimen will be compared to that in the pre-vaccination diagnostic biopsy. The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank
  • Difference in HER2 expression in the biopsy and the surgical specimen excised post-vaccination [ Time Frame: Pre-vaccination to up to 9 months after completion of the vaccination series timepoint ]
    HER2 scoring will be determined according to the American Society of Clinical Oncology/College of American Pathologists clinical guidelines. Pre-vaccination and post-vaccination specimens will be compared. The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank corr
  • Immune infiltrates in normal tissue maximally distant from the tumor (in mastectomy samples) [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete biomarkers will be tested by chi-square or Fisher's exact test. Paired t-test/Wilcoxon rank sum test and McNemar's test may be used to test the change
  • Immune infiltration as determined by immunohistochemistry staining for CD3, CD4 and CD8 [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    Total number of positive cells for each immune cell marker in 10 high power fields in the DCIS samples from pre-treatment and post-treatment samples will be counted and a "difference statistic" for each participant will be calculated (the change in the total number of marker-positive infiltrating immune cells in the pre- and post-treatment samples for each participant). These biomarker data will be visualized by plotting each participant's pre- and post-treatment value ("spaghetti plots"). The average "difference statistic" will then be calculated for the HER2 vaccine-treated group and the GM-
  • In vivo immune response to nelipepimut-S determined by delayed type hypersensitivity reaction [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    For each patient, pre- and post-vaccination DTH measurements will be compared. DTH data will be presented as means ± standard errors and compared (pre- vs post-vaccination) using a Student t test.
  • Incidence of adverse events, graded according to NCI CTCAE v 4.03 [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    Adverse events by grade and relationship will be summarized by tabulation for each group.
  • Polyfunctional cytokine responses assessed by multiplex assays [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    A standard curve will be generated for each cytokine and the cytokine concentration in individual patient samples will be determined by comparison to that standard curve. The association among various continuous and discrete biomarkers or treatment groups will be assessed by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot and trellis plot, etc., and may be tested by t-test/ANOVA/Wilcoxon rank sun test/Kruskal-Wallis test, when appropriate. Correlation between continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The associati
  • Presence of DCIS at resection [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    The histologic data will be presented in tabular form to examine whether the vaccine treatment is associated with the absence of DCIS, induction of necrosis, reduction in histologic grade, or a reduction in the size of DCIS. These data will be descriptive only.
  • Proliferation as measured by Ki67 staining in DCIS cells [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
    The % Ki67-positive cells in the DCIS samples from pre-treatment and post-treatment samples and a "difference statistic" for each participant will be calculated (the change in % Ki67 between pre- and post-treatment sample for each participant). If the distribution of % Ki67 values is not a normal distribution, then it may be necessary to log-transform the primary % Ki67 data before calculating the difference statistic. These biomarker data will be visualized by plotting each participant's pre- and post-treatment value ("spaghetti plots"). The average "difference statistic" will then be calcula
  • Toxicity profile according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.03 [ Time Frame: Up to 9 months after completion of the vaccination series timepoint ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer
Official Title  ICMJE VADIS Trial: Phase II Trial of Nelipepimut-S Peptide Vaccine in Women With DCIS of the Breast
Brief Summary This randomized 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. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.
Detailed Description

PRIMARY OBJECTIVES:

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. Immune response to other tumor antigens (epitope spreading). III. Functional capacity of the immune response to vaccination. IV. Determine CTL functional capability using intracellular cytokine assays. V. Evaluate polyfunctional cytokine responses assessed by multiplex assay. VI. Presence of DCIS at resection. VII. Difference in human epidermal growth factor receptor 2 (HER2) expression in the biopsy and the surgical specimen excised post-vaccination.

VIII. Histologic responses: degree of lymphocyte infiltration determined on hematoxylin and eosin (H&E) stained slides and by immunohistochemistry staining for CD3, CD4 and CD8.

IX. Histologic responses: Ki67 in DCIS cells (proliferation). X. Cleaved caspase 3 in DCIS cells (apoptosis). XI. Immune infiltrates in normal tissue maximally distant from the tumor (in mastectomy samples).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nelipepimut-S plus GM-CSF vaccine intradermally (ID) 2 vaccination 2 weeks apart prior to surgery.

ARM II: Patients receive sargramostim ID 2 vaccinations 2 weeks apart prior to surgery, and 3 vaccinations 1 months apart post-surgery.

After completion of study treatment, patients are followed up at 1 and 3 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Ductal Breast Carcinoma In Situ
Intervention  ICMJE
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Drug: Nelipepimut-S Plus GM-CSF Vaccine
    Given ID
    Other Names:
    • E75 Plus GM-CSF
    • E75 Vaccine Plus GM-CSF
    • HLA A2/A3-Restricted HER-2/neu Peptide Vaccine Plus GM-CSF
    • Nelipepimut-S Plus Sargramostim
    • NeuVax Plus GM-CSF
  • Biological: Sargramostim
    Given ID
    Other Names:
    • 23-L-Leucinecolony-Stimulating Factor 2
    • DRG-0012
    • Leukine
    • Prokine
    • rhu GM-CFS
    • Sagramostim
    • Sargramostatin
Study Arms  ICMJE
  • Experimental: Arm I (nelipepimut-S plus GM-CSF vaccine)
    Patients receive nelipepimut-S plus GM-CSF vaccine ID 2 vaccination 2 weeks apart prior to surgery.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Drug: Nelipepimut-S Plus GM-CSF Vaccine
  • Experimental: Arm II (sargramostim)
    Patients receive sargramostim ID 2 vaccinations 2 weeks apart prior to surgery.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Biological: Sargramostim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 18, 2019)
13
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2015)
108
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must be pre- or post-menopausal
  • Participants must have a diagnosis of DCIS made by core needle biopsy
  • Participants must be human leukocyte antigen (HLA)-A2 positive
  • Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 (Karnofsky >= 60%)
  • Platelets >= 100,000/mm^3
  • Hemoglobin >= 10 g/dL
  • Blood urea nitrogen < 2 x upper limit of normal (ULN)
  • Alkaline phosphatase < 2 x ULN
  • Lactate dehydrogenase < 2 x ULN
  • Creatinine < 2 x ULN
  • Bilirubin < 2 x ULN
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2 x ULN
  • A normal ejection fraction, as defined by the participant's institution; only limited echocardiograms (ECHOs) will be used as cardiac evaluation; no other tests are allowed; ECHO is to be done only in HLA-A2 positive participants; If ECHO has been done within 30 days prior to randomization and results showing a normal ejection fraction have been obtained prior to randomization, an additional ECHO is not needed at baseline
  • Willingness to comply with all study interventions and follow-up procedures
  • The ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  • Invasive breast cancer; areas of microinvasion or suspicious for microinvasion on the core biopsy is allowed
  • History of prior breast cancer treated within the past two years; patients completing all breast cancer-specific treatment over two years prior to the current diagnosis are eligible
  • History of prior ductal carcinoma in situ (DCIS) treated within the past two years; patients completing all treatment for a previous diagnosis of DCIS over two years prior to the current diagnosis are eligible
  • Prior lobular carcinoma in situ (LCIS) is allowed
  • Pregnant, unwilling to use adequate contraception during study treatment duration or breastfeeding; pregnant women will be excluded; all heterosexually active women who may become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation OR be post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
  • Any autoimmune disease or other medical condition that, in the opinion of the investigator, would compromise the subject's safety
  • Immune deficiency diseases such as immunoglobulin deficiency or immunosuppressive therapy that might interfere with appropriate immune response
  • Known history of or known active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
  • Patients on chronic steroid therapy or other immunosuppressive therapy except for topical or inhaled steroids known to have low systemic absorption
  • Patients with a known hypersensitivity to GM-CSF, yeast-derived products, or any component of the GM-CSF product (e.g., mannitol)
  • Concurrent treatment with other investigational agent
  • History of non-breast malignancy within 5 years prior to randomization, except curatively treated superficial bladder cancer, carcinoma in situ of the cervix (stage 0-1), and basal cell or squamous cell carcinoma of the skin
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to NeuVax
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No recent or planned immunotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02636582
Other Study ID Numbers  ICMJE NCI-2015-02189
NCI-2015-02189 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N01-CN-2012-00034
2016-0164 ( Other Identifier: M D Anderson Cancer Center )
MDA2014-04-02 ( Other Identifier: DCP )
N01CN00034 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth A Mittendorf M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP