Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
RATIONALE: A vaccine made from a person's myelodysplasia cells may make the body build an immune response to kill cancer cells. Combining vaccine therapy with sargramostim may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have myelodysplastic syndrome.
|Leukemia Myelodysplastic Syndromes||Biological: ras peptide cancer vaccine Biological: sargramostim||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Vaccination of Patients With Myelodysplastic Syndrome Against Mutated RAS Proteins: A Pilot Trial|
|Study Start Date:||June 1999|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine whether a specific T-cell response can be induced in patients with myelodysplastic syndrome treated with mutant N-, K-, or H-ras peptide vaccine (limited to the specific N-, K-, or H-ras peptide mutation in their bone marrow) and intradermal sargramostim (GM-CSF). II. Determine whether HLA type or the ability to respond immunologically to common recall antigens correlates with the induction of anti-ras immune responses in these patients treated with this regimen. III. Assess toxicity of mutant N-, K-, or H-ras peptide vaccine in these patients.
OUTLINE: Patients receive sargramostim (GM-CSF) intradermally on days 1-10. Patients receive mutant N-, K-, or H-ras peptide vaccine (limited to the specific N-, K-, or H-ras mutation in their bone marrow) intradermally on day 7. Treatment repeats every 4 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 and 6 weeks after the last vaccination.
PROJECTED ACCRUAL: A total of 25-70 patients will be accrued for this study over 12-15 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003959
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Stephen D. Nimer, MD||Memorial Sloan Kettering Cancer Center|