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Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer (Breast 41)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
Patrick Dillon, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01532960
First received: February 8, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

Despite advances in surgical, radiation and medical therapies of early stage breast cancer, some patients will experience disease recurrence. Because recurrence may not happen for years after definitive treatment, there is a period of time between resection and relapse when micrometastatic disease may be amenable to immune eradication or modulation. While the ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast immunotherapy is to define treatments that have immunologic efficacy. In this study, the investigators will determine whether a vaccine consisting of nine-class I breast specific peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.


Condition Intervention
Breast Cancer
Biological: 9 Peptides from Her-2/neu, CEA, & CTA + poly-ICLC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage IB-IIIA Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Frequency of dose limiting adverse events. [ Designated as safety issue: Yes ]
  • Immune response rate as measured by the number of IFN-gamma producing cells/well in a direct ELIspot assay of PBMCs collected at 30 days from the last peptide + poly-ICLC vaccination. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of serious adverse events from the time of enrollment as defined by CTCAEv4.03 [ Designated as safety issue: Yes ]
  • Characterize responding peripheral CD8+ T-cell specificity by tetramer staining and measure by standardized flow cytometric criteria at 30 days post vaccine. [ Designated as safety issue: No ]
  • The CD8+ T-cell activation as measured by cytokine bead assay upon peptide stimulation at 30 days from last vaccine. [ Time Frame: 30 days from last vaccine ] [ Designated as safety issue: No ]
  • The frequency of immune responses among patients treated with anti-estrogen therapies [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: 9 Peptides from Her-2/neu, CEA, & CTA + poly-ICLC
    Each vaccination will be administered on days 1, 8, 15, 36, 57, and 78. For each vaccination, the participants will receive an emulsion containing 100 mcg of each of the 9 peptides, plus 200 mcg of the tetanus toxoid peptide, plus 1 mg poly-ICLC in sterile water.
Detailed Description:

The study is a single arm, open label, pilot study of safety and immune efficacy of peptide vaccination with poly-ICLC in patients with stage IB-IIIA resected breast cancer. Participants will be patients who have completed their last dose/treatment of any single treatment or combination of adjuvant surgery, radiation, chemotherapy or trastuzumab therapy between 45 days and 6 months (180 days) prior to enrollment.

Each vaccination will be administered on days 1, 8, 15, 36, 57, and 78. All participants will receive 9 class I MHC-restricted synthetic peptides (restricted by HLA-A1, -A2, -A3, or -A31) and a class II MHC-restricted tetanus helper peptide mixed with 1mg poly-ICLC and administered in sterile water. The vaccine will be administered intramuscular (IM) (1 ml) and intradermally (ID) (1 ml) at vaccination sites in the arm and leg. (Each vaccine given IM and ID at one site; site to alternate between arm site opposite the breast cancer and an anterior thigh site.) Participants will be screened for HLA type and must be HLA-A1, -A2, -A3, or -A31 (80% of the Virginia population in prior studies1).

Annual follow-up for progression and survival for 3 years after study withdrawal/completion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • AJCC clinical or pathologic stage IB-IIIA adenocarcinoma of the breast (male or female) who have completed primary surgery and/or chemotherapy and/or radiation therapy and/or anti-Her2 therapy.
  • >45 days and <6months (180 days) from completion of their last dose/treatment of any single treatment or combination of surgery, chemotherapy, radiation or trastuzumab..
  • Participants must have tumor pathology report demonstrating breast cancer (from breast tumor or lymph node).
  • ECOG performance status of 0 -1
  • HLA-A1, -A2, -A3, or -A31 positive
  • Adequate marrow function, to include: ANC >1000/mm3, Platelets >100,000/mm, Hgb >9 g/dL
  • Adequate organ function to include:

    • AST and ALT ≤ 2.5 x upper limits of normal (ULN)
    • Bilirubin ≤ 2.5 x ULN
    • Alkaline phosphatase ≤ 2.5 x ULN
    • Creatinine ≤ 1.5 x ULN
  • HIV and Hepatitis C negative

Exclusion Criteria

  • Participants with known or suspected allergies to any component of the vaccine
  • Participants who have an active infection requiring antibiotics.
  • Allergy desensitization injections
  • Corticosteroids, administered parenterally, orally, or inhaled. Inhaled steroids (e.g., Advair®, Flovent®, Azmacort®) are not permitted while patient is on study or within the 6 weeks (42 days) prior to consenting. Topical corticosteroids are acceptable.
  • Growth factors (e.g., Procrit®, Aranesp®, Neulasta®) while patient is on study
  • Other agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)
  • Active autoimmune disorders requiring cytotoxic or immunosuppressive therapy within the 6 weeks (42 days) prior to consenting.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532960

Contacts
Contact: Emily Allred, PhD 434-982-1902 EH4M@virginia.edu
Contact: Kristy Scott 434-982-6714 ks4ww@virginia.edu

Locations
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Emily Allred, PhD    434-982-1902    EH4M@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Patrick M Dillon, MD University of Virginia
  More Information

No publications provided

Responsible Party: Patrick Dillon, MD, Assistant Professor UVA Division of Hematology/Oncology, University of Virginia
ClinicalTrials.gov Identifier: NCT01532960     History of Changes
Other Study ID Numbers: 15881
Study First Received: February 8, 2012
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
breast cancer
peptide vaccine
immunotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Poly ICLC
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014