Study Using Vaccination With Heat Shock Protein 70 (HSP70) for the Treatment of CML in Chronic Phase (NCT00027144) | Clinical Trial Compass
CompletedPhase 1
Study Using Vaccination With Heat Shock Protein 70 (HSP70) for the Treatment of CML in Chronic Phase
United States10 participantsStarted 2000-12
Plain-language summary
Description: The trial is designed to determine the response of the immune system of patients with CML 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, alerts the body's immune system to recognize and attack invading cancer. To be considered potentially eligible for this study you must have CML in the chronic phase.
Length/Duration: Vaccinations will be administered weekly for eight weeks. One clinic follow up visit will be scheduled two weeks after the final vaccination.
Who can participate
Age range
18 Years
Sex
ALL
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
Inclusion:
* ECOG Performance Score(PS) less than 2.
* Must be at least 18 years of age and capable of giving informed consent.
* Must be less than three years from the original diagnosis of Philadelphia chromosome positive CML in chronic phase.
* Patient is not in cytogenetic remission.
* No anticipation of bone marrow or stem cell transplant for six months unless these therapies are deemed necessary by a treatment physician due to the evolution of the disease;
* Concurrent treatment with hydroxyurea or Gleevec is allowed.PAST treatment with IFN alpha, Ara-C or other cytoxic agents is allowed
* Must not have any serious illness such that their medical condition might be compromised by participation in the study.
* Must have adequate renal function (serum creatinine \< 2.0), hepatic function (bilirubin and transaminase less than 2.0 x of the upper normal limit).
* Must not be on corticosteroid therapy, or other immunosuppressive medications.
Exclusion
* Patients with an ECOG Performance Score greater than or equal to 2.
* Patient is greater than or equal to 3 years out from the original diagnosis.
* Significant anemia (Hemoglobin \< 10 g/dl) and thrombocytopenia (platelet \< 20,000/ml) requiring transfusion.
* Peripheral blast count is over 10%.
* Positive urine or blood pregnancy test.
* Impaired renal function (serum creatinine \> 2.0), hepatic function (bilirubin and transaminase more than 2.0 x of the upper normal limit).
* Patient with significant active …
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.