Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers
Completed · Phase 2
Conditions studied: Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML)
In brief
This study will test the safety and effectiveness of two vaccines on slowing disease progression, improving blood counts, reducing the need for transfusions of blood and platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). The vaccines consist of peptides (parts of proteins) found in MDS, AML and CML stem cells, combined with a substance called "MontanideTM". They are administered with granulocyte- macrophage colony- stimulating factor (GM-CSF). The Montanide and the GM-CSF help the immune system respond to the vaccines. People 18 years of age or older with MDS, AML or CML may be eligible for this study. Participants receive six injections of the vaccines, one dose every other week for a total of 10 weeks. The injections are given in the upper arm, upper leg, or abdomen. A separate injection of GM-CSF is given in the same area as the vaccine injections. Subjects are observed for 2 hours after the first vaccination and at least 30 minutes after each subsequent vaccination for allergic reactions. In addition to the vaccination, subjects undergo the following: * History and physical exam, chest x-ray, blood tests and bone marrow aspirate and biopsy before starting the vaccinations. * Safety monitoring during vaccine administration (every other week for 10 weeks) with blood tests and check of vital signs. * Follow-up safety monitoring (weeks 12 and 16) with blood tests every visit, chest x-ray at week 12 and bone marrow biopsy visit 16.
Key facts
- Study ID
- NCT00488592
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 10
- Starts
- 2007-06-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2021-07-12
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
- Hypocellular bone marrow (less than 20%)
- 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 or immunosuppressants within 14 days prior to study entry
- Co-morbidity of such severity that it would preclude the patient's ability to tolerate protocol therapy
- Predicted survival less than 28 days
- Pregnant or breast feeding (All female patients must have a urine pregnancy test within 1 week prior to vaccine administration)
- Unwilling to practice abstinence or effective contraception (men and women) during the study period.
- 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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