Leukemia Clinical Trial
Official title:
Phase 2 Study of Proteinase 3 PR1 Peptide Vaccine in Myelodysplastic Syndrome (MDS)
Primary aim:
1. To determine the immunologic response, using a PR1-HLA-A2 tetramer assay, to 4
subcutaneous (SQ) injections of TVC-PR1 vaccine formulated in Montanide ISA 51 VG
followed by granulocyte macrophage colony-stimulating factor (GM-CSF) in low risk and
intermediate-1 myelodysplastic syndrome (MDS) patients.
Secondary aims:
1. To determine if non-immunologic responders to 4 subcutaneous (SQ) injections of TVCPR1
vaccine formulated in Montanide ISA 51 VG followed by GM-CSF can be converted to
immunologic responders by administering 4 additional doses of TVC-PR1 vaccine
formulated in Montanide ISA 51 VG followed by GM-CSF.
2. To determine the clinical response to 4 or 8 subcutaneous (SQ) injections of TVC-PR1
vaccine formulated in Montanide ISA 51 VG followed by GM-CSF in patients low risk and
intermediate-1 MDS.
MDS cells over-produce proteins found in normal bone marrow cells. These proteins can be
used to stimulate the body's immune system to kill the MDS cells. PR-1 is a peptide derived
from a protein, and PR1 peptide vaccine is given to help immune cells kill MDS cells. The
vaccine is given together with granulocyte macrophage colony stimulating factor (GM-CSF),
which increases production of white blood cells and is intended to increase the number of
immune cells.
Before you can start treatment on the study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in the study. You will have a
bone marrow aspirate (about 1 tablespoon) for routine tests and for special studies. To
collect a bone marrow aspirate, an area of the hip is numbed with anesthetic and a small
amount of bone marrow is withdrawn through a large needle. Blood (about 6 tablespoons) will
be drawn. The blood tests are being done to compare pre-treatment blood counts to
post-treatment counts, and the aspirate is being done to allow comparison of the number of
MDS cells before and after treatment. Both the blood counts and aspirate will show whether
the therapy was successful. Women who are able to have children must have a negative blood
pregnancy test.
If you are found to be eligible to take part in this study, you will receive the PR-1
vaccine as an injection under the skin once every 3 weeks. You will receive a total of 4
vaccinations. Each vaccination requires 4 shots: 2 of PR-1 vaccine and 2 of GM-CSF. GM-CSF
is given to increase the number of immune cells that might respond to the vaccine and
eventually kill MDS cells. PR-1 vaccine is mixed with montanide ISA 51, which is used to
dissolve and stabilize the vaccine.
Blood (about 1 tablespoon) will be drawn for routine tests 1 time every 3 weeks and (about 3
tablespoons) will be drawn each time before you receive the vaccinations and at follow up
visits for the length of the study. You will have a bone marrow aspiration 4 weeks after the
4th and 8th vaccinations (about 1 tablespoon) for routine and for the special tests. These
tests will allow researchers to find out if the number of immune cells has increased,
whether these cells are able to attack the MDS cells, and whether the cells are related to a
change in blood counts. At this time (13 weeks from the first PR-1 vaccine), if your immune
system is reacting to the vaccinations, no further vaccinations will be given. This is to
avoid production of immune cells that might block the effects of the cells already produced
by the first 4 vaccinations. If, at this time (13 weeks from the first PR-1 vaccine), your
immune system is not reacting to the drug, you will be offered an additional 4 vaccinations.
These additional vaccinations will again be given once every 3 weeks. During this time,
blood (about 4 tablespoons) will again be drawn once every 3 weeks for routine and special
testing.
You will be taken off study at any time if the disease gets worse or intolerable side
effects occur.
Twenty-nine (29) weeks after beginning the study, blood (about 1 teaspoon) will be drawn to
check for a response to the vaccine. If you have not responded, you will be taken off study.
If you have responded, you will continue to be followed. Follow-up will involve monthly
routine blood tests (1 tablespoon of blood) for 6 months. These can be done at home with
results sent to M. D. Anderson. Every 3 months, you will return to M. D. Anderson for a bone
marrow aspirate and routine blood tests including the special testing studies.
This is an investigational study. This vaccine is authorized for use in research only and is
not commercially available. About 30 patients will take part in this multicenter study.
About 20 patients will be enrolled at M. D. Anderson.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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