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 .

Condition	Treatment or Intervention	Phase
Refractory Anemia Previously Treated Myelodysplastic Syndrome secondary myelodysplastic syndrome refractory anemia with ringed sideroblasts de novo myelodysplastic syndrome refractory anemia with excess blasts Chronic Myelomonocytic Leukemia	Drug: ras peptide cancer vaccine  Drug: sargramostim	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  17 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven myelodysplastic syndrome (MDS) with 1 of the following classifications: Refractory anemia; Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts; Chronic myelomonocytic leukemia; History of MDS, received chemotherapy for acute leukemia within past 12 months, and now in remission
• Myelodysplastic disease must be stable (not anticipated to require chemotherapy for at least 4 months)
• Must have 1 of the following N-, K-, or H-ras peptide mutations: Progenitor cells contain aspartic acid, valine, or serine substitution at codon 12, OR Aspartic acid or arginine substitution at codon 13

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: No concurrent immunosuppressive drugs including systemic steroids or antiinflammatory drugs
• Radiotherapy: No prior irradiation of spleen
• Surgery: No prior splenectomy

--Patient Characteristics--

• Age: Over 17
• Performance status: ECOG 0 or 1
• Life expectancy: Greater than 5 months
• Hematopoietic: WBC at least 1,500/mm3; Platelet count at least 50,000/mm3
• Hepatic: Not specified
• Renal: Not specified
• Cardiovascular: No New York Heart Association class III or IV heart disease
• Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other medical condition that might prevent completion of study or prevent immunological response to study regimen; No other concurrent serious medical illness; No active bleeding

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Stephen D. Nimer,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067158; MSKCC-98037; NCI-G99-1542
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003959
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08