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HER2-positive Breast CancerPhase 1/2NCT01355393

Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer

A Phase 1/2 study testing HER-2/neu peptide vaccine, sargramostim and rintatolimod in people with HER2-positive Breast Cancer and Male Breast Cancer, run by University of Washington 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
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Trial summary

This randomized phase I/II trial studies the side effects and best dose of rintatolimod when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HER-2/neu peptide vaccine, sargramostim and rintatolimod
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Jul 2011to Nov 2013
Phase
Phase 1/2
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 with stage II, or III HER2+ breast cancer who have completed definitive standard treatment and are in complete remission - or -
  • Patients with stage IV HER2+ breast cancer treated to:
  • No evidence of disease, or
  • Stable bone only disease after definitive therapy
  • Patients must have demonstrated HER2 positive disease, by one of the following methods:
  • Immunohistochemical (IHC) staining of 1+, 2+ or 3+ for the HER2 protein, or
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  • Amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
  • Patients must be at least 14 days post cytotoxic chemotherapy prior to enrollment
  • Patients must be at least 14 days post systemic steroids prior to enrollment
  • Patients on bisphosphonates or continued hormone therapy are eligible
  • Men and women of reproductive ability must agree to contraceptive use during the entire study period
  • Patients must have Zubrod Performance Status Score of =< 2
  • Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
  • White blood cell count (WBC) >= 3000/mm^3
  • Hemoglobin (Hgb) >= 10 mg/dl
  • Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min
  • Total bilirubin =< 1.5 mg/dl
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times the upper limit of normal
  • Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fractions (EF) on multi gated acquisition scan (MUGA) scan or echocardiogram performed within the last 3 months of eligibility sign off

Who cannot join

  • Restrictive cardiomyopathy
  • Unstable angina within 6 months prior to enrollment
  • New York Heart Association functional class III-IV heart failure
  • Symptomatic pericardial effusion
  • Patients with any contraindication to receiving rhuGM-CSF based products
  • Patients with any clinically significant autoimmune disease requiring active treatment
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  • Patients receiving any concurrent immunomodulators within 30 days of eligibility sign-off
  • Patients who are pregnant or breast-feeding
  • Patients who are simultaneously enrolled in any other treatment study
  • Patients who have received a previous HER2 breast cancer vaccine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase I-II Study of HER2 Vaccination With Poly(I) • Poly(C12U) (Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients

This randomized phase I/II trial studies the side effects and best dose of rintatolimod when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells that express HER-2/neu. Adjuvant therapies, such as GM-CSF and rintatolimod, are additional cancer treatments given after the primary treatment to lower the risk that the cancer will come back and are one way to help vaccines produce stronger immune responses. Giving vaccine therapy together with rintatolimod and/or GM-CSF may be a safe and effective treatment for breast cancer.

Read the detailed description

OBJECTIVES:

  1. To choose the most promising (maximum biologic dose [MBD]) of five different doses (4, 20, 79, 495 and 2000 mcg) of Ampligen (rintatolimod) administered intradermally (i.d.) as an adjuvant with HER2 vaccination, with respect to toxicity and incidence and magnitude of immune response.

II. To determine, using MBD of Ampligen (defined in first primary aim), whether Ampligen when given with GM-CSF as a combined adjuvant strategy with HER2 vaccination increases both the incidence and magnitude of HER2 Th1 immunity as compared to the standard GM-CSF adjuvant strategy.

OUTLINE: This will be a phase I-II randomized two-stage HER2 vaccine study in breast cancer patients.

STUDY STAGE I: There are five groups of patients randomized to 1 of 5 arms with each arm receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses) given i.d.

STUDY STAGE II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive the synthetic HER-2/neu peptide vaccine admixed with rintatolimod given i.d.

ARM II: 24 patients will receive the HER-2/neu peptide vaccine admixed with GM-CSF and the other 24 patients will receive the HER-2/neu peptide vaccine admixed with GM-CSF in addition to rintatolimod (dose set by Stage I group that had the most active response) given i.d.

In both study stages, treatment repeats every month for up to 3 months in the absence of disease progression or unacceptable toxicity.

After completion of last vaccine, patients are followed up at 1 and 12 months.

Being tested
HER-2/neu peptide vaccine, sargramostim, rintatolimod
Keywords
Breast Cancer, HER2+, Vaccine, Stage II, Stage III, Stage IV
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms

What participants receive

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

  • HER-2/neu peptide vaccineBiological

    Also called HER-2

    Given ID

  • sargramostimBiological

    Also called GM-CSF, Leukine, Prokine

    Given ID

  • rintatolimodDrug

    Also called Ampligen, atvogen, poly(I):poly(C12U) RNA

    Given ID

Study groups in NCT01355393
Study groupRoleWhat they receive
Stage I, Arm 1 (HER-2/neu peptide vaccine and rintatolimod)ExperimentalArm 1: HER2 peptide vaccine + 4 mcg Ampligen® Five groups of randomized patients with each group receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses).
Receives: Biological: HER-2/neu peptide vaccine; Drug: rintatolimod
Stage II, Arm I (HER-2/neu peptide vaccine and sargramostim)Active comparatorPatients receive synthetic HER-2/neu peptide vaccine admixed with GM-CSF ID.
Receives: Biological: HER-2/neu peptide vaccine; Biological: sargramostim
Stage II, Arm II (HER-2 vaccine, sargramostim, rintatolimod)ExperimentalPatients receive synthetic HER-2/neu peptide vaccine admixed with GM-CSF and rintatolimod ID
Receives: Biological: HER-2/neu peptide vaccine; Biological: sargramostim; Drug: rintatolimod
Stage I, Arm 2 (HER-2/neu peptide vaccine and rintatolimod)ExperimentalArm 2: HER2 peptide vaccine + 20 mcg Ampligen® Five groups of randomized patients with each group receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses).
Receives: Biological: HER-2/neu peptide vaccine; Drug: rintatolimod
Stage I, Arm 3 (HER-2/neu peptide vaccine and rintatolimod)ExperimentalArm 3: HER2 peptide vaccine + 79 mcg Ampligen® Five groups of randomized patients with each group receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses).
Receives: Biological: HER-2/neu peptide vaccine; Drug: rintatolimod
Stage I, Arm 4 (HER-2/neu peptide vaccine and rintatolimod)ExperimentalArm 4: HER2 peptide vaccine + 495 mcg Ampligen® Five groups of randomized patients with each group receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses).
Receives: Biological: HER-2/neu peptide vaccine; Drug: rintatolimod
Stage I; Arm 5 (HER-2/neu peptide vaccine and rintatolimod)ExperimentalArm 5: HER2 peptide vaccine + 2000 mcg Ampligen® Five groups of randomized patients with each group receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses).
Receives: Biological: HER-2/neu peptide vaccine; Drug: rintatolimod

What is being measured

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

  1. Evaluation of immune response among the different treatment arms in Stage I and II

    Standard interferon (IFN)-gamma enzyme-linked immunospot (ELISPOT) assay will be used to evaluate CD4+ 1 T cell responses to HER2 immunizing peptides.

    Measured: Up to 12 months post-vaccination

  2. Evaluation of safety and systemic toxicity among the different treatment arms in Stage I and II

    Toxicity grading will be evaluated per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) 4.0 and monitoring of adverse events (AEs) will be done per Food and Drug Administration (FDA) and National Cancer Institute (NCI) guidelines.

    Measured: Up to 4 months

Secondary outcomes (2)

  1. Disease-free survival

    Though not statistically powered to this endpoint, large differences if observed between the vaccine treatment groups will be noted and described.

    Measured: Time from study enrollment to time of first event, assessed up to 12 months post-vaccination

  2. Overall survival

    Though not statistically powered to this endpoint, large differences if observed between the vaccine treatment groups will be noted and described.

    Measured: Time from study enrollment to time of first event, assessed up to 12 months post-vaccination

Timeline

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

  1. First posted18 May 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2013

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355393
Sponsor's protocol ID
7425
Other IDs
NCI-2011-00658, 7425/133, 133 [Tumor Vaccine Group], 7425, P30CA015704
Status last verified
Jun 2019
First submitted
16 May 2011
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HER-2/neu peptide vaccine, sargramostim and rintatolimod in people with HER2-positive Breast Cancer and Male Breast Cancer, run by University of Washington 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 19 inclusion and 10 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 10 Feb 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Evaluation of immune response among the different treatment arms in Stage I and II (time frame: Up to 12 months post-vaccination). 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 NCT01355393.

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 10 Feb 2020.

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