Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

NCT ID: NCT00304096

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-04-30

Brief 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 kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the safety of a vaccine comprising multiple synthetic breast cancer-associated peptides and a tetanus toxoid helper peptide emulsified in Montanide ISA-51 in patients with stage III or IV adenocarcinoma of the breast.
• Determine, preliminarily, the frequency of immune responses against the 9 class I MHC-restricted peptides in patients treated with the vaccine.
• Determine, preliminarily, the cytotoxic responses of T-cells to allogeneic breast cancer cells and autologous breast cancer cells (when available).

OUTLINE: This is an open-label study.

Patients receive peptide vaccine comprising 9 synthetic breast cancer peptides and tetanus toxoid helper peptide emulsified in Montanide ISA-51 subcutaneously and intradermally once daily on days 1, 8, 15, 36, 57, and 78 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stratum 1: Receiving Hormone Therapy

Patients treated with 9 peptide vaccine who received hormone therapy

Group Type: EXPERIMENTAL

synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine

Intervention Type: BIOLOGICAL

Stratum 2: Not receiving hormone therapy

Patients receiving 9 peptide vaccine who did not receive hormone therapy

Group Type: EXPERIMENTAL

synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine

Intervention Type: BIOLOGICAL

Interventions

synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the breast

• Stage III or IV disease
• Primary or recurrent disease
• Invasive lobular carcinoma allowed
• HLA-A1, -A2, -A3, or -A31 positive
• Underwent and recovered from prior primary therapy

• Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months
• Must have at least one undissected axillary and/or inguinal lymph node basin
• No history of brain metastases
• Hormone receptor status

• Estrogen receptor-positive or -negative tumor

PATIENT CHARACTERISTICS:

• ECOG performance status of 0 or 1
• Body weight > 110 lbs (without clothes)
• Male or female
• Menopausal status not specified
• Absolute neutrophil count > 1000/mm^3
• Platelet count > 100,000/mm^3
• Hemoglobin > 9 g/dL
• Hemoglobin A1c < 7%
• AST and ALT ≤ 2.5 x upper limit of normal (ULN)
• Bilirubin ≤ 2.5 x ULN
• Alkaline phosphatase ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN
• HIV negative
• Hepatitis C negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known or suspected allergies to any component of the vaccine
• No active infection requiring antibiotics
• No New York Heart Association class III or IV heart disease
• No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:

• Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
• Clinical evidence of vitiligo
• Other forms of depigmenting illness
• Mild arthritis requiring nonsteroidal antiinflammatory drugs
• No medical contraindication or potential problem that would preclude study participation

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior surgery
• More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy
• More than 4 weeks since prior and no concurrent allergy desensitization injections
• More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids

• No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)
• Prior or concurrent topical corticosteroids allowed
• More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)
• More than 4 weeks since prior and no concurrent other investigational medication
• More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents
• Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed
• No prior vaccination with any synthetic peptides in this protocol

• Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered ≥ 2 weeks prior to or ≥ 2 weeks after study vaccine
• Short term therapy for acute conditions not related to breast cancer allowed
• No concurrent illegal drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R. Brenin, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

UVACC-BREAST-34

Identifier Type: -

Identifier Source: secondary_id

UVACC-HIT-032.7

Identifier Type: -

Identifier Source: secondary_id

UVACC-PRC-366-05

Identifier Type: -

Identifier Source: secondary_id

UVACC-GCRC-DRB001

Identifier Type: -

Identifier Source: secondary_id

11992

Identifier Type: -

Identifier Source: org_study_id