Leukemia,Myeloid, Chronic Clinical Trial
Official title:
A Feasibility and Toxicity Study of Vaccination With HSP70 for the Treatment of Chronic Myelogenous Leukemia in the Chronic Phase
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 infection requiring hospitalization at the time of enrollment. - Patient with significant behavioral or psychological problems that prevent adequate follow-up. - Concurrent treatment with IFN alpha Ara-C or other cytotoxic agents (Gleevec and hydroxyurea are allowed. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Connecticut Health Center | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
University of Connecticut |
United States,
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