Vaccine Therapy in Treating Women With Metastatic Breast Cancer

NCT ID: NCT00003184

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-08-31
• Study Completion Date: 2003-07-31

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.

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

BCG vaccine

Intervention Type: BIOLOGICAL

CD80 breast cancer vaccine

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Providence Cancer Center, Earle A. Chiles Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

Walter J. Urba, MD, PhD

Role: STUDY_CHAIR

Providence Cancer Center, Earle A. Chiles Research Institute

Locations

Earle A. Chiles Research Institute at Providence Portland Medical Center

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 10026920 (View on PubMed)

Other Identifiers

PPMC-IRB-94-78

Identifier Type: -

Identifier Source: secondary_id

OCC-ONC-9408-L

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1379

Identifier Type: -

Identifier Source: secondary_id

CDR0000066010

Identifier Type: -

Identifier Source: org_study_id