Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy
Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
This study will determine the safety and effectiveness of an experimental vaccine in
controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also
known as myelodysplasia), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL),
and chronic myeloid leukemia (CML). It will test whether the vaccine can increase the number
of immune cells responding to the cancer and thereby slow progression of the illness, improve
blood counts, reduce the need for transfusions of blood and platelets, or even achieve a
disease remission. The vaccine contains part of a protein that is produced in large amounts
by cells of patients with these cancers and an added substance called Montanide that helps
the immune system respond to the vaccine. Sargramostim, another substances that boosts the
immune response, is also given.
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.