Safety of Peptide Vaccination for Patients With Myelodysplastic Syndrome
Completed · Phase 1
Conditions studied: Myelodysplastic Syndrome (MDS)
In brief
This study will test whether certain patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML) can safely be vaccinated with two peptide vaccines derived from proteins called proteinase 3 (PR1) and Wilm's tumor-1 (WT1). These proteins are produced in large amounts by cells of MDS, AML and CML patients. The peptides are combined with an "adjuvant" called Montanide to make the vaccines, and the vaccines are given with GM-CSF (sargramostim). Both Montanide and sargramostim help the immune system respond to the vaccines. The vaccines then activate the immune system to make specialized cells that search out and kill the MDS, AML and CML cells containing the two proteins. Patients with MDS, AML or CML who are 18 years of age or older may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, chest x-ray, and bone marrow aspirate and biopsy. For the bone marrow biopsy, the area of the hip is anesthetized and a special needle is used to draw marrow from the hipbone. Participants receive an injection (shot) of each peptide vaccine into deep tissue of the upper arm, upper leg, or the abdomen and two separate shots of sargramostim in the same area as the vaccine shots. Patients' vital signs (heart rate, breathing rate, temperature, blood pressure) are measured before and after they receive the vaccines and they are watched for 2 hours after the shots for possible side effects, such as chills, pain at the injection site, stomach upset, allergic reaction, low blood counts, and infection. Patients return to the clinic 1, 2, 3 and 4 weeks after receiving the vaccines for a brief physical evaluation and blood tests. A chest x-ray is also done at the 4-week visit. Patients may receive whole blood or platelet transfusions if needed to treat the MDS, growth factors (filgrastim, erythropoietin, or others) if needed, and medications to treat any infections that may develop.
Key facts
- Study ID
- NCT00270452
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 9
- Starts
- 2005-12-22
- Expected to finish
- 2007-10-26
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Hypoplastic MDS
- Relapsed AML
- CML in accelerated phase or blast crisis
- Relapsed MDS, AML or CML following hematopoietic stem cell transplantation
- Hb less than 9 g/dl, neutrophil count less than 1 times 10(9)/1, and/ or platelet count less than 75 times 10(9)/1
- Hypocellular bone marrow
- History of Wegener's granulomatosis
- Serologic antibody against proteinase-3 (ANCA positive)
- Previous allergic reaction to montanide adjuvant
- Positive test for HIV
- Treatment with systemic corticosteroids within 14 days prior to study entry
- Co-morbidity of such severity that it would preclude the subject's ability to tolerate protocol therapy
- Predicted survival less than 28 days
- Pregnant or breast feeding (All female subjects must have a urine pregnancy test within 1 week prior to vaccine administration)
- Enrolled in another drug or vaccine clinical trial during the study period
- Inability to comprehend the investigational nature of the study and provide informed consent
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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