NCT01355393

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Last Updated

February 10, 2020

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

May 16, 2011

Last Update Submit

February 4, 2020

Conditions

HER2-positive Breast CancerMale Breast CancerRecurrent Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Keywords

Breast CancerHER2+VaccineStage IIStage IIIStage IV

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 12 months post-vaccination

  • 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.

    Up to 4 months

Secondary Outcomes (2)

  • Disease-free survival

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

  • Overall survival

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

Study Arms (7)

Stage I, Arm 1 (HER-2/neu peptide vaccine and rintatolimod)

EXPERIMENTAL

Arm 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).

Biological: HER-2/neu peptide vaccineDrug: rintatolimod

Stage II, Arm I (HER-2/neu peptide vaccine and sargramostim)

ACTIVE COMPARATOR

Patients receive synthetic HER-2/neu peptide vaccine admixed with GM-CSF ID.

Biological: HER-2/neu peptide vaccineBiological: sargramostim

Stage II, Arm II (HER-2 vaccine, sargramostim, rintatolimod)

EXPERIMENTAL

Patients receive synthetic HER-2/neu peptide vaccine admixed with GM-CSF and rintatolimod ID

Biological: HER-2/neu peptide vaccineBiological: sargramostimDrug: rintatolimod

Stage I, Arm 2 (HER-2/neu peptide vaccine and rintatolimod)

EXPERIMENTAL

Arm 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).

Biological: HER-2/neu peptide vaccineDrug: rintatolimod

Stage I, Arm 3 (HER-2/neu peptide vaccine and rintatolimod)

EXPERIMENTAL

Arm 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).

Biological: HER-2/neu peptide vaccineDrug: rintatolimod

Stage I, Arm 4 (HER-2/neu peptide vaccine and rintatolimod)

EXPERIMENTAL

Arm 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).

Biological: HER-2/neu peptide vaccineDrug: rintatolimod

Stage I; Arm 5 (HER-2/neu peptide vaccine and rintatolimod)

EXPERIMENTAL

Arm 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).

Biological: HER-2/neu peptide vaccineDrug: rintatolimod

Interventions

HER-2/neu peptide vaccineBIOLOGICAL

Given ID

Also known as: HER-2
Stage I, Arm 1 (HER-2/neu peptide vaccine and rintatolimod)Stage I, Arm 2 (HER-2/neu peptide vaccine and rintatolimod)Stage I, Arm 3 (HER-2/neu peptide vaccine and rintatolimod)Stage I, Arm 4 (HER-2/neu peptide vaccine and rintatolimod)Stage I; Arm 5 (HER-2/neu peptide vaccine and rintatolimod)Stage II, Arm I (HER-2/neu peptide vaccine and sargramostim)Stage II, Arm II (HER-2 vaccine, sargramostim, rintatolimod)
sargramostimBIOLOGICAL

Given ID

Also known as: GM-CSF, Leukine, Prokine
Stage II, Arm I (HER-2/neu peptide vaccine and sargramostim)Stage II, Arm II (HER-2 vaccine, sargramostim, rintatolimod)
rintatolimodDRUG

Given ID

Also known as: Ampligen, atvogen, poly(I):poly(C12U) RNA
Stage I, Arm 1 (HER-2/neu peptide vaccine and rintatolimod)Stage I, Arm 2 (HER-2/neu peptide vaccine and rintatolimod)Stage I, Arm 3 (HER-2/neu peptide vaccine and rintatolimod)Stage I, Arm 4 (HER-2/neu peptide vaccine and rintatolimod)Stage I; Arm 5 (HER-2/neu peptide vaccine and rintatolimod)Stage II, Arm II (HER-2 vaccine, sargramostim, rintatolimod)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +4 more criteria

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast Neoplasms

Interventions

sargramostimGranulocyte-Macrophage Colony-Stimulating Factorpoly(I).poly(c12,U)

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Lupe Salazar

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 18, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2013

Last Updated

February 10, 2020

Record last verified: 2019-06

Locations

US(1)