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

Breast Cancer Clinical Trial

Official title:

Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304096
• Other study ID #: 11992
• Secondary ID: UVACC-BREAST-34U
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2006
• Last updated: February 26, 2013
• Start date: December 2005
• Est. completion date: April 2008

Study information

• Verified date: February 2013
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine

Locations

Country	Name	City	State
United States	University of Virginia Cancer Center	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Who Experienced Dose-limiting Adverse Events	Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity	30 days post administration of last vaccine	Yes
Secondary	The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization		Days 1-78	No