Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer

NCT00640861 | Completed Early Phase 1 DMC

• 5 other identifiers: CDR0000589446P30CA015083MC0338NCI-2009-01342782-05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is most effective in treating breast cancer. PURPOSE: This randomized clinical trial is studying the side effects of three different vaccine therapies and comparing the vaccines to see how well they work in treating patients with previously treated stage II or stage III breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IA breast cancer; stage IB breast cancer; triple-negative breast cancer; HER2-positive breast cancer

Outcome Measures

Primary Outcomes (3)

• Percentage of CD4+ T cells, CD8+ T cells, B cells, monocytes, and dendritic cells in a patient's peripheral blood sample as estimated by flow cytometry with a panel of monoclonal antibodies

• Frequency of peptide-specific IFN-gamma producing T cells and peptide-specific IL-5 producing T cells estimated by ELISPOT after in vitro stimulation with peptide-sensitized stimulator cells for MUC1 and HER-2 peptides

• Number and severity of hematologic and non-hematologic toxicities reported using the NCI-CTC version 3.0 criteria

Secondary Outcomes (2)

• Disease-free survival, defined as the time from registration to the documentation of a first failure where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer

• Overall survival, defined as the time from registration to death due to any cause

Interventions

CpG oligodeoxynucleotide BIOLOGICAL

HER-2/neu peptide vaccine BIOLOGICAL

MUC-1 peptide vaccine BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

sargramostim BIOLOGICAL

immunoenzyme technique OTHER

immunologic technique OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Clinical stage II or III disease * No radiographic evidence of disease at the time of enrollment * Has undergone surgery, adjuvant chemotherapy, and/or radiotherapy * Completed "standard first-line therapy" only (including adjuvant therapy) for breast cancer within the past 3 months and currently with no evidence of disease * Patients with stage I breast cancer with high-risk features are eligible provided 1 of the following criteria are met: * HER2 over-expression or amplification * Triple-negative (i.e., no expression of ER, PR, or over-expression of HER2 on routine immunohistochemical staining) * . * MUC1-positive breast cancer * HLA-A2 positive * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-2 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 75,000/μL * ANC ≥ 1,500/uL * Creatinine ≤ 2 times upper limit of normal (ULN) * AST ≤ 2 times ULN * No uncontrolled infection * No known HIV infection * No other circumstances (e.g., concurrent use of systemic immunosuppressants or immunocompromising condition) that in the opinion of the physician would render the patient a poor candidate for this trial * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior invasive malignancies within the past 5 years (with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Fully recovered from acute, reversible effects of any prior breast cancer therapy * No more than 3 years since prior surgery for primary breast cancer * Concurrent anti-estrogen therapy is allowed * No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation) * No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

CPG-oligonucleotide; incomplete Freund's adjuvant; sargramostim; Immunoenzyme Techniques; Immunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoassay; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Svetomir Markovic, MD, PhD

  Mayo Clinic

  STUDY CHAIR

• Barbara A Pockai, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Edith A Perez, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 21, 2008
• Study Start: August 28, 2008
• Primary Completion: April 21, 2015
• Study Completion: April 21, 2015
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (3)