Evaluating the T Cell Response to a Peptide-based Vaccine in Patients With Breast Cancer

NCT00892567 | Completed Phase 1 DMC

• 2 other identifiers: 12911R21CA130340
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate T cell responses against a peptide-based vaccine in patients with breast cancer and to determine whether peptide-specific T cells can be found at the site of breast tumors following vaccination.

Conditions

Breast Neoplasms

Keywords

breast cancer; peptide vaccine; immunotherapy

Outcome Measures

Primary Outcomes (1)

• To evaluate whether a multi-peptide vaccine induces T cells that traffic to and penetrate into human primary breast cancers.

  22 days following initiation of the vaccines

Secondary Outcomes (1)

• To characterize the T cell response to a peptide-based vaccine in terms of antigen specificity and the induction of differentiated effector cells, both in the peripheral blood and within the tumor microenvironment.

  1 year

Study Arms (1)

9 Peptide Vaccine

EXPERIMENTAL

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

Interventions

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

Each vaccination will be administered on days 1, 8, 15, 36, 43, and 50. All participants will receive 9 class I MHC-restricted synthetic peptides and a class II MHC-restricted tetanus helper peptide administered in Montanide ISA-51. The vaccine will be administered subcutaneously (1 ml) and intradermally (1ml) at a single vaccination site.

9 Peptide Vaccine

Eligibility Criteria

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

You may qualify if:

• Patients with a mass approximately ≥1 cm by breast imaging, BIRADS 5
• Patients who have been diagnosed, by cytologic or histologic examination, with adenocarcinoma (including invasive lobular carcinoma) of the breast and have not yet undergone primary surgery for their disease.
• All participants must have:
• ECOG performance status of 0 or 1
• Ability and willingness to give informed consent
• Laboratory parameters as follows:
• HLA-A1, -A2, -A3, or -A31 (+)
• ANC \> 1000/mm3
• Platelets \> 100,000/mm3
• Hgb \> 11 g/dL
• HGBA1C \< 7%
• 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

You may not qualify if:

• Patients who require neoadjuvant chemotherapy prior to surgery for the treatment of their disease.
• Participants with known or suspected allergies to any component of the vaccine.
• Participants who have an active infection requiring antibiotics.
• Participants receiving the following medications or treatments at study registration or within the preceding 30 days are excluded:
• Surgery
• Chemotherapy
• Radiation therapy
• Allergy desensitization injections
• Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair®, Flovent®, Azmacort®) are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex®).
• Growth factors (e.g., Procrit®, Aranesp®, Neulasta®)
• Any investigational medication
• Participants may not have been vaccinated previously with any of the synthetic peptides included in this protocol.
• Pregnancy during vaccine administration. Female participants of childbearing potential must have a negative pregnancy test (urinary or serum β-HCG) prior to administration of the first vaccine dose. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination.
• Female participants must not be breastfeeding.
• Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.

Sponsors & Collaborators

• Craig L Slingluff, Jr: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• David R. Brenin, M.D.

  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: April 30, 2009
• First Posted: May 4, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

US (1)