PR1 Vaccination in Myelodysplastic Syndrome (MDS)

This is an interventional treatment trial for Leukemia focused on measuring myelodysplastic syndrome, MDS, PR1 Peptide Vaccine Read More

Inclusion Criteria:

1. Must understand and voluntarily sign an informed consent form
2. Age >/= 18 years at the time of signing the informed consent form
3. Must be able to adhere to the study visit schedule and other protocol requirements
4. HLA-A2 positive at one allele
5. Diagnosis of myelodysplastic syndrome (MDS) and must meet all the following criteria
6. French-American-British (FAB) Class Refractory anemia (RA), Refractory Anemia with Excess Blasts (RAEB), refractory anemia with ringed sideroblasts (RARS)
7. World Health Organization(WHO) Classification refractory anemia (RA), refractory anemia with ringed sideroblasts(RARS), refractory cytopenia with multilineage dysplasia (RCMD), refractory cytopenia with ringed sideroblasts (RCMD-RS) , refractory anemia with excess blasts type 1 (RAEB-1)
8. Less than 20% blasts on marrow aspirate
9. International Prognostic Scoring System (IPSS) risk groups Intermediate 1 or transfusion dependent low risk.
10. Both de novo and therapy related MDS are eligible
11. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1
12. Women of childbearing potential must have a negative serum pregnancy test within 30 days of starting study drug. A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months)
13. Male or female of child-bearing potential must agree to use adequate contraceptive methods
14. Serum bilirubin < 2 mg/ml
15. Serum creatinine </= 1.5 mg/ml
16. Serum ALT < 2 x upper normal limit
17. anti-neutrophil cytoplasmic antibody (cANCA) negative
18. Not received specific therapy for MDS for 4 weeks. However, supportive therapy is permitted.

Exclusion Criteria:

1. Marrow blasts on aspirate >/= 20%
2. Blood blasts > 1%
3. Inaspirable bone marrow
4. Myelosclerosis occupying >30% of marrow space
5. Iron absence on marrow examination or transferrin saturation <20% and serum ferritin <50ng/ml
6. B-12 deficiency
7. Folate deficiency
8. History of immune related hematological disorder [i.e.,immune thrombopenia purpura(ITP),autoimmune hemolytic anemia ( AIHA)]
9. Other causes of cytopenia not related to MDS (i.e., GI blood loss)
10. 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
11. Prior allogeneic or syngeneic transplant
12. Prior solid organ transplant
13. Life expectancy severely limited by diseases other than MDS
14. Pregnant or lactating females
15. Prior vaccine therapy for MDS
16. 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)
17. 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
18. Known allergy to incomplete Freund's adjuvant
19. Experimental therapy, cyclosporine, antithymocyte globulin, or FK506 within 3 months of study entry
20. 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
21. refractory anemia with excess blasts in transformation (RAEB-t) (French-American British (FAB) criteria ) or refractory anemia with excess blasts type2 (RAEB-2) (World Health Organization (WHO) criteria)
22. Chloroma
23. Hypercalcemia
24. Progressive viral or bacterial infection. Patients are not eligible unless all infections are resolved and the patient has remained afebrile for seven days without antibiotics
25. Cardiac disease of symptomatic nature or cardiac ejection fraction < 40%
26. Symptomatic pulmonary disease or FEV1, FVC and Carbon Monoxide Diffusing Capacity (DLCO) </= 50% predicted
27. History of Wegener's Granulomatosis or vasculitis
28. History of HIV positivity or AIDS
29. Prior history of AML