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Vaccination of Patients With Myelodysplastic Syndrome Against Mutated RAS Proteins: A Pilot Trial (NCT00003959)

National Cancer Institute (NCI)
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.
  • Biological: ras peptide cancer vaccine
    • Biological: sargramostim
      Ages eligible for Study
      17 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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.

      1 locations

      United States (1)
      • Memorial Sloan-Kettering Cancer Center
        New York, New York, United States, 10021
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 May, 1999
      Updated:
      14 January, 2013
      Participants:
      1
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