Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
This study will test the safety and effectiveness of two vaccines on slowing disease
progression, improving blood counts, reducing the need for transfusions of blood and
platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known
as myelodysplasia), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). The
vaccines consist of peptides (parts of proteins) found in MDS, AML and CML stem cells,
combined with a substance called "MontanideTM". They are administered with granulocyte-
macrophage colony- stimulating factor (GM-CSF). The Montanide and the GM-CSF help the immune
system respond to the vaccines.
People 18 years of age or older with MDS, AML or CML may be eligible for this study.
Participants receive six injections of the vaccines, one dose every other week for a total of
10 weeks. The injections are given in the upper arm, upper leg, or abdomen. A separate
injection of GM-CSF is given in the same area as the vaccine injections. Subjects are
observed for 2 hours after the first vaccination and at least 30 minutes after each
subsequent vaccination for allergic reactions. In addition to the vaccination, subjects
undergo the following:
- History and physical exam, chest x-ray, blood tests and bone marrow aspirate and biopsy
before starting the vaccinations.
- Safety monitoring during vaccine administration (every other week for 10 weeks) with
blood tests and check of vital signs.
- Follow-up safety monitoring (weeks 12 and 16) with blood tests every visit, chest x-ray
at week 12 and bone marrow biopsy visit 16.