Vaccine Therapy and GM-CSF in Treating Patients With Low-Risk or Intermediate-Risk Myelodysplastic Syndrome

Status unconfirmed · Phase 2

Conditions studied: Myelodysplastic Syndromes

In brief

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with low-risk or intermediate-risk myelodysplastic syndrome.

Key facts

Study ID

NCT00513578

Run by

The Vaccine Company

People needed

30

Starts

2007-01-01

Last updated by the study team

2014-01-06

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• M. D. Anderson Cancer Center at University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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