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Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Triple Negative Breast Cancer; Triple Negative Breast Neoplasms; Triple-Negative Breast Cancer

Intervention: Personalized synthetic long peptide vaccine (Poly ICLC) (Biological); Poly ICLC (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Williams E Gillanders, M.D., Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
William E Gillanders, M.D., Phone: 314-747-0072, Email: gillandersw@wustl.edu

Summary

The most important consideration in the design of this clinical trial is to ensure the safe translation of the personalized synthetic long peptide vaccine strategy. The Food and Drug Administration (FDA) dictates that initial studies of biologic therapies be performed in such a way that there is a balance between the potential risks and benefits in individual patients. Consistent with these recommendations, the investigators will target patients with triple-negative breast cancer who do not have a pathologic complete response after neoadjuvant chemotherapy. These patients typically have no gross evidence of disease following standard of care therapy (neoadjuvant chemotherapy, surgery and radiation therapy) but are at extremely high-risk for disease recurrence. Targeting this patient population provides a window-of-opportunity to design and manufacture the personalized cancer vaccines, maximizes the potential benefit from the vaccine as the regulatory networks associated with metastatic disease are not present, and balances risk in this patient population with extremely high risk for disease recurrence but no other treatment options.

Clinical Details

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety of the vaccine regimen as measured by grade and frequency of adverse events

Secondary outcome:

Immunogenicity of the vaccine regimen as measured by ELISPOT analyses

Immunogenicity of the vaccine regimen as measured by multiparametric flow cytometry

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Histologically confirmed diagnosis of invasive breast cancer.

- ER and PR less than Allred score of 3 or less than 1% positive staining cells in the

invasive component of the tumor

- HER2 negative by FISH or IHC staining 0 or 1+.

- Consented for genome sequencing and dbGAP-based data sharing and has provided or will

provide germline and tumor DNA samples of adequate quality for sequencing.

- Clinical stage T2-T4c, any N, M0 primary tumor by AJCC 7th edition clinical staging

prior to neoadjuvant chemotherapy, with residual invasive breast cancer after neoadjuvant therapy. If the patient has invasive cancer or DCIS in the contralateral breast, she is not eligible for this study.

- At least 18 years of age.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Adequate organ and marrow function no more than 14 days prior to registration as

defined below:

- WBC ≥3,000/μL

- absolute neutrophil count ≥1,500/μL

- platelets ≥100,000/μL

- total bilirubin ≤2. 5 X institutional upper limit of normal

- AST/ALT ≤2. 5 X institutional upper limit of normal

- creatinine ≤1. 5 X institutional upper limit of normal

- Women of reproductive potential 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.

- Able to understand and willing to sign an IRB-approved written informed consent

document. Exclusion Criteria:

- Evidence of progressive breast cancer within the last 30 days.

- Received chemotherapy, radiotherapy, or biologic therapy within the last 30 days

(neoadjuvant chemotherapy excluded).

- Experiencing adverse events due to agents administered more than 30 days earlier.

- Receiving any other investigational agent(s) or has received an investigational agent

within the last 30 days.

- Known metastatic disease.

- Invasive cancer or DCIS in the contralateral breast.

- Known allergy, or history of serious adverse reaction to vaccines such as

anaphylaxis, hives, or respiratory difficulty.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active

infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (including sinus bradycardia), or psychiatric illness/social situation that would limit compliance with study requirements.

- Prior or currently active autoimmune disease requiring management with

immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjorgen's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e. g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable. Any patients receiving steroids should be discussed with the PI to determine if eligible.

- Pregnant or breastfeeding. A negative serum pregnancy test is required no more than 7

days before study entry.

- The patient with a previous history of non-breast malignancy is eligible for this

study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).

- Patient must have no active major medical or psychosocial problems that could be

complicated by study participation.

- Known HIV-positive status. These patients are ineligible because of the potential

inability to generate an immune response to vaccines.

- Subjects with a strong likelihood of non-adherence such as difficulties in adhering

to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered.

Locations and Contacts

William E Gillanders, M.D., Phone: 314-747-0072, Email: gillandersw@wustl.edu

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Not yet recruiting
William E Gillanders, M.D., Phone: 314-747-0072, Email: gillandersw@wustl.edu
Elaine Mardis, Ph.D., Sub-Investigator
Timothy Eberlein, M.D., Sub-Investigator
Timothy Fleming, Ph.D., Sub-Investigator
S Peter Goedegebuure, Ph.D., Sub-Investigator
Foluso O Ademuyiwa, M.D., MPH, Sub-Investigator
A. Craig Lockhart, M.D., Sub-Investigator
Beatriz Carreno, Ph.D., Sub-Investigator
Robert Schreiber, Ph.D., Sub-Investigator
Additional Information

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Starting date: August 2015
Last updated: July 27, 2015

Page last updated: August 23, 2015

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