TerminatedPhase 1/2

Vaccination Against High Risk Breast Cancer Using Tumor Derived Heat Shock Protein 70

Stopped: difficulty with accrual

United States15 participantsStarted 2000-12

Plain-language summary

Description: The trial is designed to determine the response of the immune system of patients with breast cancer to a vaccine made from their own tumor. Researchers believe that this particular vaccine, which is made from purified heat shock proteins taken from each patient's tumor, might alert the body's immune system to recognize and attack invading cancer. To be considered potentially eligible for this study you must be a high risk breast cancer patient and have a tumor that can be removed surgically. Length/Duration: Vaccinations are administered weekly for six weeks. Follow up visits to the clinic are every three months for two years, then every six months thereafter.

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.

ELIGIBILITY Pre-registration inclusion: Must be at least 18 years of age and capable of giving informed consent. High risk breast cancer defined as the following: * stage IV breast cancer * inflammatory breast carcinoma * Stage II breast cancer with more than 10 positive axillary lymph nodes * Stage IIIA breast cancer (tumor greater than or equal to 5 cm with at least one positive axillary lymph note) A minimum of 3 grams of non-necrotic, resectable breast cancer. ECOG Performance Score (PS) less than (\<3.0). Pre-registration exclusion: * ECOG Performance Score (PS) greater than or equal to 3.0. * Congenital or acquired immunodeficiency including infection with human immunodeficiency virus. * Significant behavioral or psychological problems that preclude adequate informed consent or follow-up. Registration inclusion: * Major clinical responses defined as either Complete response (CR) by conventional staging work-up such as CT scan and bone scan. Or Stable partial response (PR) defined as more than 50% tumor reduction which remains stable by serial CT scans or bone scans over a 3-month span. * More than 60 micrograms of HSP70 purified. * ECOG Performance Score(PS) less than 3.0. * Greater than or equal to 4 weeks post cytotoxic therapy. Registration exclusion: * ECOG Performance Score(PS) greater than or equal to 3.0. * Purification of HSP70 is unsuccessful qualitatively or quantitatively. * On other investigational therapy for breast cancer. * Positive serum or…

Trial details

NCT IDNCT00027131

SponsorUConn Health

Sponsor typeOTHER

Study typeINTERVENTIONAL