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

NCT00304096 | Completed Phase 1 Results DMC

• 5 other identifiers: 11992UVACC-BREAST-34UVACC-HIT-032.7UVACC-PRC-366-05UVACC-GCRC-DRB001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; male breast cancer; invasive lobular breast carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Stratum 1: Receiving Hormone Therapy

EXPERIMENTAL

Patients treated with 9 peptide vaccine who received hormone therapy

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

Stratum 2: Not receiving hormone therapy

EXPERIMENTAL

Patients receiving 9 peptide vaccine who did not receive hormone therapy

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

Interventions

synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine BIOLOGICAL

Stratum 1: Receiving Hormone Therapy; Stratum 2: Not receiving hormone therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male; Carcinoma, Lobular

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Kimberly Bullock, PhD and David Brenin, MD
• Organization: University of Virginia

kb9d@virginia.edu

434-924-0180

Study Officials

• David R. Brenin, MD, FACS

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: December 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: April 1, 2008
• Last Updated: April 9, 2013
• Results First Posted: April 9, 2013

Record last verified: 2013-02

Locations

US (1)