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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00304096
• Date of registration: 15/03/2006
• Primary sponsor: University of Virginia
• Public title: Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
• Scientific title: Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
• Date of first enrolment: December 2005
• Target sample size: 12
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00304096
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David R. Brenin, MD, FACS
• Affiliation: University of Virginia

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

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

Primary Outcome(s)

Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity at day 36 [Time Frame: Yes]

Secondary Outcome(s)

Frequency of immune responses by Elispot assay [Time Frame: No]

Secondary ID(s)

CDR0000468669

UVACC-BREAST-34

UVACC-GCRC-DRB001

UVACC-HIC-11992

UVACC-HIT-032.7

UVACC-PRC-366-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)