Vaccination Against High Risk Breast Cancer Using Tumor Derived Heat Shock Protein 70 (NCT00027131) | Clinical Trial Compass
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 range
18 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.