Know Cancer

or
forgot password

A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage IB-IIIA Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage IB-IIIA Breast Cancer


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of dose limiting adverse events.

Safety Issue:

Yes

Principal Investigator

Patrick M Dillon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Food and Drug Administration

Study ID:

15881

NCT ID:

NCT01532960

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • peptide vaccine
  • immunotherapy
  • Breast Neoplasms

Name

Location

University of Virginia Health SystemCharlottesville, Virginia  22903