Vaccine Therapy in Treating Women With Metastatic Breast Cancer (NCT00003184) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Treating Women With Metastatic Breast Cancer
United StatesStarted 1996-08
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ventricu…
Trial details
NCT IDNCT00003184
SponsorProvidence Cancer Center, Earle A. Chiles Research Institute