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


Phase 1
17 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

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


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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen D. Nimer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-037

NCT ID:

NCT00003959

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • chronic myelomonocytic leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021