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

Inclusion Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

- Diagnosis of myelodysplastic syndromes (MDS) and must meet all of the following
criteria:

- FAB class refractory anemia (RA), RA with excess blasts (RAEB), or RA with
ringed sideroblasts (RARS)

- WHO Classification RA, RARS, refractory cytopenia with multilineage dysplasia
(RCMD), RCMD with ringed sideroblasts, or RAEB-1

- Less than 20% blasts on marrow aspirate

- IPSS risks groups intermediate-1- OR transfusion dependent low-risk

- Patients with de novo or therapy-related MDS eligible

- HLA-A2 positive at one allele

Exclusion criteria:

- RAEB in transformation or RAEB-2

- Chloroma

- Marrow blasts on aspirate ≥ 20%

- Blood blasts > 1%

- Inaspirable bone marrow

- History or current myelosclerosis occupying > 30% of marrow space

- History of acute myeloid leukemia

- Other causes of cytopenia not related to MDS (i.e., gastrointestinal blood loss)

PATIENT CHARACTERISTICS:

Inclusion criteria:

- ECOG performance status 0 or 1

- Women of childbearing potential must have a negative serum pregnancy test within 30
days of starting study drug

- Male or female of child-bearing potential must agree to use adequate contraceptive
methods

- Serum bilirubin < 2 mg/mL

- Creatinine ≤ 1.5 mg/mL

- ALT < 2 times upper normal limit

- Antineutrophil cytoplasmic antibody (cANCA) negative

Exclusion criteria:

- Pregnant or lactating

- Iron absence on marrow examination or transferrin saturation < 20% and serum ferritin
< 50ng/mL

- B12 deficiency

- Folate deficiency

- History of immune-related hematological disorder (i.e., idiopathic thrombocytopenic
purpura, autoimmune hemolytic anemia)

- Life expectancy severely limited by diseases other than MDS

- Prior history of malignancy other than MDS (except basal cell or squamous cell
carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been
free of disease for ≥ 5 years

- Known allergy to incomplete Freund's adjuvant

- Hypercalcemia

- Progressive viral or bacterial infection

- All infections must be resolved and the patient has remained afebrile for seven
days without antibiotics

- Cardiac disease of symptomatic nature or cardiac ejection fraction < 40%

- History of Wegener granulomatosis or vasculitis

- Symptomatic pulmonary disease or FEV_1, FVC, and DLCO ≤ 50% predicted

- History of HIV positivity or AIDS

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form or that will place
the subject at unacceptable risk if he/she were to participate in the study or
confounds the ability to interpret the data

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

- Has received specific therapy for MDS within the past 4 weeks

- Prior allogeneic or syngeneic transplant

- Prior solid organ transplant

- Chronic use (> 2 weeks) of greater than physiologic doses of a corticosteroid agent
(dose equivalent to > 10 mg/day of prednisone) within 30 days of the first day of
study drug treatment

- Topical and inhaled corticosteroids are permitted

- Experimental therapy, cyclosporine, antithymocyte globulin, or tacrolimus within 3
months of study entry

- Treatment with androgenic hormones, danazol, colony-stimulating factors,
erythropoietin, thalidomide, arsenic trioxide or other agents used to treat MDS
within four weeks of the first day of study treatment

- Prior vaccine therapy for MDS

- Prohibited medications during study, including any of the following:

- Systemic steroids except as required for transfusion reactions

- Chemotherapy or other investigational drugs

- Sargramostim (GM-CSF) (except as part of study regimen)

- Filgrastim (G-CSF)

- Interleukin-11