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


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Walter J. Urba, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Providence Cancer Center, Earle A. Chiles Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066010

NCT ID:

NCT00003184

Start Date:

August 1996

Completion Date:

July 2003

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Earle A. Chiles Research Institute at Providence Portland Medical CenterPortland, Oregon  97213-2967