Vaccine Therapy in Treating Women With Metastatic Breast Cancer

Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer

RATIONALE: Vaccines made from breast cancer cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccines made from breast cancer cells in treating women with metastatic breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Biological: sargramostim; Biological: BCG vaccine; Biological: CD80 breast cancer vaccine

Detailed Description

OBJECTIVES:

• Determine the safety and toxicity of vaccination strategies employing a CD80-transfected allogeneic breast cancer cell line (MDA-MB-231).
• Assess the immunologic response of lymphocytes isolated from lymph nodes draining the vaccination site following a single dose of CD80-transfected MDA-MB-231.
• Assess the development of systemic immunity following multiple injections of CD80-transfected MDA-MB-231.
• Observe for tumor regression.

OUTLINE: This is a dose-escalation study.

Patients receive intradermal vaccinations containing CD80-transfected cells with or without sargramostim (GM-CSF) or with or without BCG. Vaccinations are administered every 2 weeks for 6 weeks and then monthly for 3 months. Patients may receive 1 of 2 different doses of GM-CSF. GM-CSF is administered with the vaccination, then every 12 hours for 7 days. Monthly vaccinations may continue as long as response is shown.

Cohorts of 5 patients each are treated at each dose/combination. Each cohort completes treatment before the next cohort is accrued.

Patients are followed at weeks 4 and 8, then every 2 months for 6 months, then every 3 months for 1 year, and then every 6 months until disease progression.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 18 months.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97213-2967
      • Earle A. Chiles Research Institute at Providence Portland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

DISEASE CHARACTERISTICS:

• Histologically proven metastatic breast cancer

  • Stage IV disease patients who have either been treated to maximal response or who have had high dose chemotherapy or a marrow ablative regimen (if they meet immunologic criteria and have not received more than 2 chemotherapy regimens for treatment of metastatic disease)

  • Patients with advanced stage disease who:

    • Received at least 1 standard chemotherapy regimen, but no more than 2, for treatment of metastatic disease
    • Refused chemotherapy
    • Refused or progressed despite hormonal therapy
• Measurable or evaluable disease
• Positive or negative for HLA-A2
• Must have superficial inguinal or axillary lymph nodes that are free of tumor involvement and are surgically accessible
• No symptomatic or acutely life threatening tumor that is judged likely to require intervention with alternative modalities within 3 months
• No brain metastases

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm^3

Hepatic:

• Not specified

Renal:

• BUN less than 25 mg/dL
• Creatinine less than 1.8 mg/dL

Cardiovascular:

• No ischemic or congestive cardiac disease requiring chronic medication
• No New York Heart Association class III or IV heart disease
• No evidence of ischemic change or ventricular ectopy (greater than 4/min) on electrocardiogram (EKG)
• No evidence of type II arterial-ventricular block
• No evidence of current cardiac disease by stress test and EKG

Other:

• HIV negative
• No active infection requiring treatment
• No psychiatric illness
• No history of seizure disorder
• No other prior malignancy within the past 10 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior specific or nonspecific immunotherapy, unless there is obvious progression of metastatic disease, and recovered

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy, unless there is obvious progression of metastatic disease, and recovered

Endocrine therapy:

• At least 4 weeks since prior steroids, unless there is obvious progression of metastatic disease, and recovered

Radiotherapy:

• Concurrent radiotherapy allowed for local control of disease

Surgery:

• Not specified

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Providence Cancer Center, Earle A. Chiles Research Institute
• Investigators: Study Chair: Walter J. Urba, MD, PhD, Providence Cancer Center, Earle A. Chiles Research Institute

Publications and helpful links

General Publications

• Schoof DD, Smith JW 2nd, Disis ML, Brant-Zawadski P, Wood W, Doran T, Johnson E, Urba WJ. Immunization of metastatic breast cancer patients with CD80-modified breast cancer cells and GM-CSF. Adv Exp Med Biol. 1998;451:511-8. doi: 10.1007/978-1-4615-5357-1_79. No abstract available.

Study record dates

Study Major Dates

• Study Start: August 1, 1996
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: July 10, 2003
• First Posted (Estimate): July 11, 2003

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 2, 2013
• Last Verified: November 1, 2000

More Information

Terms related to this study

• Keywords: stage IV breast cancer; recurrent breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Vaccines; BCG Vaccine; Sargramostim
• Other Study ID Numbers: CDR0000066010; PPMC-IRB-94-78; OCC-ONC-9408-L; NCI-V98-1379