Protocol Number: 07-H-0091
Patients 18 to 85 years of age with MDS, AML, ALL or CML may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, chest x-ray and bone marrow biopsy. Women of childbearing age also have a pregnancy test. Participants undergo the following: -Chemotherapy entering the study. -Leukapheresis to collect large amounts of white blood cells for infusion before vaccine administration. -Participants may need placement of a central line (plastic tube, or catheter) in the upper part of the chest to be used for giving chemotherapy, blood or platelet transfusions, antibiotics and white blood cells, and for collecting blood samples. -Weekly vaccine injections for nine weeks, given in the upper arm, upper leg or abdomen. -Sargramostim injections following each vaccination. -Standard of care treatment for MDS, AML, ALL or CML, which may include blood or platelet transfusions, growth factors, and drugs to control underlying disease and potential side effects of the vaccine. -Weekly safety monitoring, including vital signs check, brief health assessment, blood tests and observation after the vaccination, on the day of each vaccination. -Follow-up evaluations with blood tests and chest x-ray 3 weeks after the last vaccine dose and with blood tests and bone marrow biopsy 7 weeks after the last vaccine dose.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/17/2009
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