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

NCT01532960 | Terminated Phase 1 DMC

• 1 other identifier: 15881
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer; peptide vaccine; immunotherapy

Outcome Measures

Primary Outcomes (2)

• Safety (Frequency of dose limiting adverse events)

  30 days post-administration of the last vaccine

• Immune response rate

  Measured as the number of IFN-gamma producing cells in the blood in response to the vaccine.

  through day 108

Secondary Outcomes (4)

• Safety (adverse event profile)

  30 days post-administration of the last vaccine

• Immunogenicity- CD8+ T cell specificity

  through day 108

• Immunogenicity- CD8+ cytokine production

  through day 108

• Immunogenicity- immue responses among subjects treated with anti-estrogen therapies

  through day 108

Study Arms (1)

9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLC

EXPERIMENTAL

9 class I MHC-restricted synthetic peptides (100 mcg each peptide) derived from breast cancer associated proteins, a class II MHC-restricted tetanus derived peptide (200 mcg), plus polyICLC (1 mg).

Biological: poly-ICLC; Biological: 9 Peptides from Her-2/neu, CEA, & CTA; Biological: Peptide-tet

Interventions

poly-ICLC BIOLOGICAL

poly-ICLC

9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLC

9 Peptides from Her-2/neu, CEA, & CTA BIOLOGICAL

9 synthetic peptides derived from Her-2/neu, CEA \& CTA derived breast cancer proteins.

9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLC

Peptide-tet BIOLOGICAL

A class II MHC-restricted helper peptide derived from tetanus toxoid protein.

9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IA patients must be high risk based upon triple negative status or HER2+ status
• Patients may or may not be receiving hormonal therapy at the time of study entry.
• Age ≥ 18 years at the time of enrollment
• ECOG performance status of 0 or 1
• Ability and willingness to give informed consent
• HLA-A1, -A2, -A3, or -A31 positive
• Adequate organ function
• HIV and Hepatitis C negative
• Subjects must have a minimum of two intact lymph node basins (any combination of axillary and inguinal basins that have not undergone complete nodal dissection)

You may not qualify if:

• Known or suspected allergies to any component of the vaccine
• Active infection requiring antibiotics are excluded.
• The following medications or treatments within the 4 weeks (28 days) prior to consenting. These medication and treatments may not be re-started at any time throughout the study in order to remain eligible.
• Breast tumor resection surgery (reconstructive surgery permitted)
• Chemotherapy
• Radiation therapy
• Allergy desensitization injections
• Growth factors (e.g., Procrit®, Aranesp®, Neulasta®)
• Other agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)
• Any investigational medication
• Tthe following medications or treatments within the 4 weeks (28 days) prior to consenting:
• Corticosteroids, administered parenterally, orally, or inhaled (Inhaled steroids, such as: Advair®, Flovent®, Azmacort.®)
• Topical corticosteroids are acceptable.
• Previous vaccination with any of the synthetic peptides included in this protocol.
• Active tuberculosis and not on active antitubercular agents

Sponsors & Collaborators

• Craig L Slingluff, Jr: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Dillon PM, Petroni GR, Smolkin ME, Brenin DR, Chianese-Bullock KA, Smith KT, Olson WC, Fanous IS, Nail CJ, Brenin CM, Hall EH, Slingluff CL Jr. A pilot study of the immunogenicity of a 9-peptide breast cancer vaccine plus poly-ICLC in early stage breast cancer. J Immunother Cancer. 2017 Nov 21;5(1):92. doi: 10.1186/s40425-017-0295-5.

  PMID: 29157306 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patrick M Dillon, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Human Immune Therapy Center

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 15, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

US (1)