Status:
COMPLETED
Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 cel...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00304096
Start Date
December 1 2005
End Date
April 1 2008
Last Update
April 9 2013
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908