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Breast CancerPhase 1Breast 41NCT01532960

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

A Phase 1 study testing poly-ICLC, 9 Peptides from Her-2/neu, CEA, & CTA and Peptide-tet in people with Breast Cancer, run by Craig L Slingluff, Jr at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
poly-ICLC, 9 Peptides from Her-2/neu, CEA, & CTA and Peptide-tet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Jul 2012to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have been diagnosed with clinical or pathologic stage I to stage IV adenocarcinoma of the breast (any subtype) who have undergone, and recovered from primary therapy (any combination of surgery, radiation, and/or chemotherapy and/or HER2-directed therapy), with their last dose/treatment (of any single or combination treatment) being between 28 days and 36 months prior to enrollment. Staging will be based on the Seventh Edition AJCC staging system. (Systemic staging with CT or PET scans is not required by AJCC and is not required or exclusionary for this trial).
  • 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
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  • 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)

Who cannot join

  • 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
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  • 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
  • Mild arthritis requiring NSAID medications

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage I-IV Breast Cancer

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.

Read the 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.

Conditions
Breast Cancer
Being tested
poly-ICLC, 9 Peptides from Her-2/neu, CEA, & CTA, Peptide-tet
Keywords
breast cancer, peptide vaccine, immunotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • poly-ICLCBiological

    poly-ICLC

  • 9 Peptides from Her-2/neu, CEA, & CTABiological

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

  • Peptide-tetBiological

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

Study groups in NCT01532960
Study groupRoleWhat they receive
9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLCExperimental9 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).
Receives: Biological: poly-ICLC; Biological: 9 Peptides from Her-2/neu, CEA, & CTA; Biological: Peptide-tet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (Frequency of dose limiting adverse events)

    Measured: 30 days post-administration of the last vaccine

  2. Immune response rate

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

    Measured: through day 108

Secondary outcomes (4)

  1. Safety (adverse event profile)

    Measured: 30 days post-administration of the last vaccine

  2. Immunogenicity- CD8+ T cell specificity

    Characterize vaccine specific peripheral CD8+ T-cell specificity by tetramer staining and flow cytometric analysis

    Measured: through day 108

  3. Immunogenicity- CD8+ cytokine production

    Estimate the Tc1/Tc2 cytokine production bias of circulating vaccine-specific T cells.

    Measured: through day 108

  4. Immunogenicity- immue responses among subjects treated with anti-estrogen therapies

    Using the ELIspot assay, describe the frequency of immune responses among patients treated with anti-estrogen therapies

    Measured: through day 108

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

Why it stopped: Futility for immune responses to the vaccine. Also, a component of study drug was in short supply.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01532960
Sponsor's protocol ID
15881
Acronym
Breast 41
Status last verified
May 2020
First submitted
8 Feb 2012
Last updated
8 May 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29157306

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing poly-ICLC, 9 Peptides from Her-2/neu, CEA, & CTA and Peptide-tet in people with Breast Cancer, run by Craig L Slingluff, Jr at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Futility for immune responses to the vaccine. Also, a component of study drug was in short supply.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (Frequency of dose limiting adverse events) (time frame: 30 days post-administration of the last vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01532960, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.

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