Vaccine Therapy in Treating Women With Metastatic Breast Cancer

Providence Cancer Center, Earle A. Chiles Research Institute

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Biological: sargramostim; Biological: BCG vaccine; Biological: CD80 breast cancer vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00003184

OCC-ONC-9408-L

CDR0000066010

NCI-V98-1379

PPMC-IRB-94-78

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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