Clinical trial · Interventional
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
NCT00003184CI-TRIAL-00009879completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG vaccine | Biological | — | UNRESOLVED |
| CD80 breast cancer vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 specifiedReferences
Publications (1)
- RESULTSchoof 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 10026920