PR1 Vaccination in Myelodysplastic Syndrome (MDS)

Stopped early · Phase 2

Conditions studied: Leukemia, Myelodysplastic Syndrome

In brief

Primary aim: 1. To determine the immunologic response, using a PR1-HLA-A2 tetramer assay, to 4 subcutaneous (SQ) injections of TVC-PR1 vaccine formulated in Montanide ISA 51 VG followed by granulocyte macrophage colony-stimulating factor (GM-CSF) in low risk and intermediate-1 myelodysplastic syndrome (MDS) patients. Secondary aims: 1. To determine if non-immunologic responders to 4 subcutaneous (SQ) injections of TVCPR1 vaccine formulated in Montanide ISA 51 VG followed by GM-CSF can be converted to immunologic responders by administering 4 additional doses of TVC-PR1 vaccine formulated in Montanide ISA 51 VG followed by GM-CSF. 2. To determine the clinical response to 4 or 8 subcutaneous (SQ) injections of TVC-PR1 vaccine formulated in Montanide ISA 51 VG followed by GM-CSF in patients low risk and intermediate-1 MDS.

Key facts

Study ID

NCT00893997

Run by

M.D. Anderson Cancer Center

People needed

12

Starts

2006-07-01

Expected to finish

2009-03-01

Last updated by the study team

2012-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must understand and voluntarily sign an informed consent form
• Age >/= 18 years at the time of signing the informed consent form
• Must be able to adhere to the study visit schedule and other protocol requirements
• HLA-A2 positive at one allele
• Diagnosis of myelodysplastic syndrome (MDS) and must meet all the following criteria
• French-American-British (FAB) Class Refractory anemia (RA), Refractory Anemia with Excess Blasts (RAEB), refractory anemia with ringed sideroblasts (RARS)
• 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)
• Less than 20% blasts on marrow aspirate
• International Prognostic Scoring System (IPSS) risk groups Intermediate 1 or transfusion dependent low risk.
• Both de novo and therapy related MDS are eligible
• Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1
• 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)
• Male or female of child-bearing potential must agree to use adequate contraceptive methods
• Serum bilirubin < 2 mg/ml
• Serum creatinine </= 1.5 mg/ml
• Serum ALT < 2 x upper normal limit
• anti-neutrophil cytoplasmic antibody (cANCA) negative
• Not received specific therapy for MDS for 4 weeks. However, supportive therapy is permitted.

You may not qualify if…

• Marrow blasts on aspirate >/= 20%
• Blood blasts > 1%
• Inaspirable bone marrow
• Myelosclerosis occupying >30% of marrow space
• Iron absence on marrow examination or transferrin saturation <20% and serum ferritin <50ng/ml
• B-12 deficiency
• Folate deficiency
• History of immune related hematological disorder [i.e.,immune thrombopenia purpura(ITP),autoimmune hemolytic anemia ( AIHA)]
• Other causes of cytopenia not related to MDS (i.e., GI blood loss)
• 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 allogeneic or syngeneic transplant
• Prior solid organ transplant
• Life expectancy severely limited by diseases other than MDS
• Pregnant or lactating females
• Prior vaccine therapy for MDS
• 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)
• 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
• Experimental therapy, cyclosporine, antithymocyte globulin, or FK506 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
• 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)
• Chloroma
• Hypercalcemia
• 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
• Cardiac disease of symptomatic nature or cardiac ejection fraction < 40%

Where it is running

• U.T. M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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