HER-2 Protein Vaccine in Treating Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068614
• Other study ID #: PMXA1103
• Secondary ID: CWRU-030339CDR00
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2003
• Last updated: February 4, 2014
• Start date: July 2003

Study information

• Verified date: February 2014
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• HER-2/neu peptide vaccine

Locations

Country	Name	City	State
United States	Ireland Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,