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 range18 Years
SexALL
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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 …