NCT00003184

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1996

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2003

Completed
Last Updated

April 4, 2013

Status Verified

November 1, 2000

First QC Date

November 1, 1999

Last Update Submit

April 2, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

BCG vaccineBIOLOGICAL
CD80 breast cancer vaccineBIOLOGICAL
sargramostimBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (1)

Earle A. Chiles Research Institute at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Related Publications (1)

  • 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.

    PMID: 10026920RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BCG Vaccinesargramostim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Walter J. Urba, MD, PhD

    Providence Cancer Center, Earle A. Chiles Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 11, 2003

Study Start

August 1, 1996

Study Completion

July 1, 2003

Last Updated

April 4, 2013

Record last verified: 2000-11

Locations

US(1)