HER-2 Protein Vaccine in Treating Women With Breast Cancer

February 4, 2014 updated by: Case Comprehensive Cancer Center

A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC (PX104.1.6) In Patients With Breast Cancer

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the safety of HER-2 protein AutoVac™ in women with breast cancer.

Secondary

  • Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients.
  • Determine the kinetics of the immune response to HER-2/neu in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive HER-2 protein AutoVac™ intramuscularly at weeks 0, 2, 6, and 10 in the absence of unacceptable toxicity.

Patients are followed for up to 6 weeks.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 3 months.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5055
        • Ireland Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following:

    • Metastatic disease currently in complete or partial response or stable disease

      • Have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days OR status post oophorectomy

    • Completed a course of local and adjuvant systemic therapy for high-risk stage II or III disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria:

      • Stage IIB with involvement of at least 4 nodes
      • Stage IIIA (T3 disease with involvement of at least 4 nodes)
      • Any stage IIIB or IIIC disease
    • Stage IV with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere)
  • 1+, 2+, or 3+ HER2/neu expression by immunohistochemistry
  • Treatment with trastuzumab (Herceptin®) not clinically indicated

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL
  • Absolute neutrophil count at least 1,500/mm^3

Hepatic

  • ALT or AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver metastases)
  • Bilirubin no greater than 2 mg/dL (unless due to Gilbert's disease)

Renal

  • Creatinine no greater than 2 mg/dL

Cardiovascular

  • No history of significant cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No poorly controlled cardiac arrhythmia
  • No New York Heart Association class III or IV heart disease
  • LVEF at least 50% by MUGA

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix
  • No concurrent severe autoimmune disease
  • No other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 months since prior trastuzumab
  • No prior anticancer vaccine therapy
  • No concurrent trastuzumab
  • No concurrent immunomodulators (e.g., thalidomide or interferons/interleukins)

Chemotherapy

  • More than 4 weeks since prior chemotherapy
  • No concurrent low-dose methotrexate or cyclophosphamide
  • No concurrent cytotoxic chemotherapy

Endocrine therapy

  • See Disease Characteristics

  • No concurrent corticosteroids

    • Topical or inhaled steroids are allowed
  • No changes to current endocrine therapy regimen (e.g., discontinuation or addition of an agent)

Radiotherapy

  • More than 3 months since prior radiotherapy involving more than 25% of the bone marrow
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • No prior bilateral breast procedures

Other

  • More than 4 weeks since prior immunosuppressive therapy
  • More than 30 days since prior investigational agents or clinical trial participation
  • No other concurrent experimental or investigational agents
  • No concurrent cyclosporine
  • No concurrent immunosuppressive agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Beth A. Overmoyer, MD, FACP, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 10, 2003

First Submitted That Met QC Criteria

September 10, 2003

First Posted (Estimate)

September 11, 2003

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMXA1103
  • CWRU-030339
  • CDR0000327784 (Registry Identifier: PDQ (Physician Data Query))
  • PHARMEXA-PX104.1.6-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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