Phase 1
N=11
Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00304096 ↗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
| Outcome | Result | p-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
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.