Phase 2 Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA 51 VG Adjuvant and Administered With GM-CSF in Low Risk and Intermediate-1 MDS
OBJECTIVES:
Primary
- To determine the immunologic response, using a PR1-HLA-A2 tetramer assay, to 4
subcutaneous injections of PR1 leukemia peptide vaccine formulated in incomplete
Freund's adjuvant (IFA) followed by sargramostim (GM-CSF) in patients with low- and
intermediate-1-risk myelodysplastic syndromes.
Secondary
- To determine if non-immunologic responders to 4 subcutaneous injections of PR1 leukemia
peptide vaccine formulated in IFA followed by GM-CSF can be converted to immunologic
responders by administering 4 additional doses of this treatment.
- To determine the clinical response to 4 or 8 subcutaneous injections of this vaccine.
OUTLINE: This is a multicenter study.
Patients will receive proteinase PR1 leukemia peptide vaccine (TVC-PR1) conjugated with
incomplete Freund's adjuvant administered subcutaneously with sargramostim (GM-CSF).
Patients will receive a series of four vaccinations at 3-week intervals. Non-immunologic
responders after 4 doses of vaccine are eligible to receive 4 additional doses of TVC-PR1
vaccine with the same dose and same dosing intervals. Patients who mount an immunologic
response after 4 doses will not receive additional doses of TVC-PR1 vaccine.
After completion of study therapy, patients are followed monthly for up to 6 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Immunologic response after four injections of vaccine formulation as determined by an increase in the absolute PR1-HLA-A2 tetramer count by at least 0.5/μl
No
Craig S. Rosenfeld, MD
Study Chair
The Vaccine Company
United States: Food and Drug Administration
CDR0000558127
NCT00513578
January 2007
Name | Location |
---|---|
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |