Vaccine Therapy and GM-CSF in Treating Patients With Low-Risk or Intermediate-Risk Myelodysplastic Syndrome
Recruitment status was: Active, not recruiting
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with low-risk or intermediate-risk myelodysplastic syndrome.
Biological: PR1 leukemia peptide vaccine
Biological: incomplete Freund's adjuvant
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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 [ Designated as safety issue: No ]
- Conversion of non-immunologic responders to immunologic responders by administering 4 additional doses of vaccine [ Designated as safety issue: No ]
- Clinical response as determined by modified IWG criteria [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513578
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Craig S. Rosenfeld, MD||The Vaccine Company|