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Phase 1 N=11 Treatment

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

Breast Cancer

Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Apr 2013
Primary outcome: Primary: The Number of Participants Who Experienced Dose-limiting Adverse Events — 1; 0 participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Virginia
Primary completion
Jun 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
The Number of Participants Who Experienced Dose-limiting Adverse Events
1; 0
SECONDARY
The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization
5; 3

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00304096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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