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

Stopped early · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01532960

Run by

Craig L Slingluff, Jr

People needed

11

Starts

2012-07-01

Expected to finish

2015-09-01

Last updated by the study team

2020-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Pregnancy.
• Female subjects must not be breastfeeding
• A medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator
• New York Heart Association classification as having Class III or IV heart disease
• Stage IV subjects who have anticipated chemotherapy need within the 108 day treatment period for this trial.
• Subjects that have experienced active autoimmune disorders requiring cytotoxic or immunosuppressive therapy within the 6 weeks (42 days) prior to consenting.
• The following will not be exclusionary:
• The presence of laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
• Clinical evidence of vitiligo
• Other forms of depigmenting illness

Where it is running

• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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