AzTrials
AzTrials

Breast CancerEarly Phase 1NCT00986609

MUC1 Vaccine for Triple-negative Breast Cancer

A Early Phase 1 study testing MUC-1 peptide vaccine, poly ICLC and MUC1 peptide-poly-ICLC adjuvant vaccine in people with Breast Cancer and Inflammatory Breast Cancer, run by Joseph Baar, MD, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
MUC-1 peptide vaccine, poly ICLC and MUC1 peptide-poly-ICLC adjuvant vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
19 Aug 2009to 21 Jan 2016
Phase
Early 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • AJCC stage I-III infiltrating adenocarcinoma of the breast who have completed standard adjuvant or neoadjuvant therapy (surgery, radiation, biologic therapy, chemotherapy) for TNBC (ER-, PR-, HER-2/neu-)
  • Patients who have completed standard therapy for triple-negative inflammatory BC are eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Absolute neutrophil count >= 1,000/mm^3
  • Hemoglobin >= 10.0 g/dl
  • Platelet count >= 100,000/mm^3
Show all 17Show fewer
  • Total bilirubin must be within normal limits
  • Transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is =< ULN
  • Alkaline phosphatase may be up to 4 x ULN if transaminases are =< ULN
  • Normal creatinine and blood urea nitrogen (BUN); if abnormal, calculated creatinine clearance must be >= 60 mg/dL
  • Human immunodeficiency virus (HIV)(-), antinuclear antibody (ANA)(-), hepatitis panel (-), normal thyroid function tests; these tests will be performed at the discretion of the Investigator if warranted by history or clinical presentation
  • Patients must be disease-free of prior invasive malignancies for >= 5 years, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • All patients must have completed surgery with sentinel and/or axillary lymph node dissection according to participating institutional guidelines
  • All patients must have completed adjuvant radiation therapy according to participating institutional guidelines
  • All patients must have completed either adjuvant or neoadjuvant chemotherapy according to participating institutional guidelines; the choice of chemotherapy is at the discretion of the treating physician
  • Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using an accepted and effective barrier form method of contraception during participation in the study and for a reasonable period thereafter
  • Patients must provide written informed consent

Who cannot join

  • Known metastatic BC
  • Radiotherapy, chemotherapy, biologic therapy, or other investigational therapy within the preceding 4 weeks
  • Previous splenectomy or radiotherapy to spleen
  • Coexisting or previous malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • Active or uncontrolled infection
  • Psychiatric, addictive, or any disorder that compromises the ability to give informed consent to participate in or to comply with the requirements of the study
  • Concurrent systemic corticosteroid treatment - must be off all steroids for at least 4 weeks prior to vaccine administration
  • Any condition or behavior that in the judgment of the Investigator, would compromise the patient's ability to participate in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer

RATIONALE:

Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

PURPOSE:

To evaluate the efficacy of poly-ICLC + MUCI peptide vaccine in boosting the immunologic response to MUCI in patients with triple-negative BC

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the efficacy of MUC1 peptide-poly-ICLC adjuvant vaccine in boosting systemic immunity to MUC1 in women who have completed therapy for AJCC(American Joint Committee on Cancer)stage I-III 'triple-negative' [i.e., ER(-) PR(-) HER2/neu(-)] breast cancer.

SECONDARY OBJECTIVES:

  1. To evaluate the safety and toxicity of the MUC1 peptide and poly-ICLC vaccine in this cohort of patients.

OUTLINE:

Patients receive MUC-1 peptide vaccine subcutaneously (SC) and poly-ICLC vaccine SC in weeks 0, 2, and 10 in the absence of disease progression or unacceptable toxicity. Some patients may receive a booster vaccine in week 52. Patients will be followed for study-related Serious Adverse Events (SAEs) for a period of 30 days after their last vaccination. If a patient experiences a SAE while participating in this study, they will be followed until the resolution of the SAE.

Being tested
MUC-1 peptide vaccine, poly ICLC, MUC1 peptide-poly-ICLC adjuvant vaccine, laboratory biomarker analysis, enzyme-linked immunosorbent assay
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • MUC-1 peptide vaccineBiological

    Given subcutaneously

  • poly ICLCBiological

    Also called Hiltonol, poly I:poly C with poly-1-lysine stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose

    Given intramuscularly

  • MUC1 peptide-poly-ICLC adjuvant vaccineBiological

    Receive adjuvant vaccination

  • laboratory biomarker analysisOther

    Correlative studies

  • enzyme-linked immunosorbent assayOther

    Also called ELISA

    Correlative studies

  • flow cytometryOther

    Correlative studies

Study groups in NCT00986609
Study groupRoleWhat they receive
Arm IExperimentalPatients receive MUC-1 peptide vaccine subcutaneously and poly-ICLC vaccine intramuscularly in weeks 0, 4, 8, 12, 52, and 56, in the absence of disease progression or unacceptable toxicity. Patients may receive additional vaccines in weeks 34 and 38 if anti-MUC1 immunity falls below the two-fold enhancement from baseline
Receives: Biological: MUC-1 peptide vaccine; Biological: poly ICLC; Biological: MUC1 peptide-poly-ICLC adjuvant vaccine; Other: laboratory biomarker analysis; Other: enzyme-linked immunosorbent assay; Other: flow cytometry

What is being measured

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

  1. Proportion of patients showing a positive anti-MUC1 antibody response

    Defined as a >= 2-fold enhancement from baseline anti-MUC1 antibody immunity, or for subjects with no antibody to MUC1 at baseline, any detectable antibody immunity against MUC1. To test the hypothesis of a sufficient immunologic response, we will apply a Simon's optimum 2-stage design. The proportion of patients with an immunologic response will be calculated with a 95% confidence interval using method developed for multistage clinical trials.

    Measured: At week 12 (2 weeks after the 3rd injection)

Secondary outcomes (1)

  1. Safety and toxicity as assessed by NCI CTC

    Measured: Weeks 0, 2, 4, 10, 12, 52, and 54 and then for 30 days after completion of study treatment

Timeline

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

  1. First posted30 Sep 2009 (estimated)
  2. Study start19 Aug 2009
  3. Primary completion29 Aug 2013
  4. Study completion21 Jan 2016

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
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00986609
Sponsor's protocol ID
CASE16107
Other IDs
NCI-2009-01318
Status last verified
Jul 2018
First submitted
29 Sep 2009
Last updated
23 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.

    PubMed 40443562

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MUC-1 peptide vaccine, poly ICLC and MUC1 peptide-poly-ICLC adjuvant vaccine in people with Breast Cancer and Inflammatory Breast Cancer, run by Joseph Baar, MD, PhD 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 17 inclusion and 8 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: finished, as of the sponsor's last update on 23 Jul 2018. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of patients showing a positive anti-MUC1 antibody response (time frame: At week 12 (2 weeks after the 3rd injection)). 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 NCT00986609, 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 23 Jul 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in