Safety of ON 01910.Na in Patients With Myelodysplasia
Myelodysplastic Syndrome (MDS)
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring Myelodyplastic Syndrome (MDS), Selective Mitotic Inhibitor, Targeted Therapy, Myelodysplastic Syndrome, MDS
Eligibility Criteria
- All patients 18-85 years old with RAEB1 or RAEB 2 MDS or refractory AML with trisomy 8 who lack a suitable matched sibling marrow will be considered for enrollment. Patients who have a suitable matched sibling donor will be referred for consideration of allogeneic bone marrow transplantation. Patients not willing to undergo transplantation or have relapsed following transplantation will be considered for protocol participation.
INCLUSION CRITERIA:
Histologically documented or cytologically confirmed diagnosis of MDS with WHO classification of RAEB-1 or 2 or Intermediate to High IPSS risk group.
OR
Refractory acute myelogenous leukemia (AML) with trisomy 8
Anemia requiring transfusion support with at least one unit of packed red blood cells per month for greater than or equal to 2 months
OR
Anemia (hemoglobin less than 9 or a reticulocyte count less than 60,000/microL)
OR
thrombocytopenia (platelet count less than 50,000/microL)
OR
neutropenia (absolute neutrophil count less than 500/microL).
- Failed to respond to, relapsed following, or opted not to participate in bone marrow transplantation or other standard of care treatment options.
- ECOG Performance Status of 0, 1, or 2.
- Off all other treatments for MDS or AML (except filgrastim (G-CSF), erythropoietin, and transfusion support and related medications) for at least four weeks. Filgrastim (G-CSF) can be used before, during and after the protocol treatment for patients with documented neutropenia (less than 500/microL) as long as they meet the criteria for anemia and/or thrombocytopenia as stated above. Post transplant patients may continue to receive DLIs as needed.
- Ages 18-85.
EXCLUSION CRITERIA:
- Active infection not adequately responding to appropriate therapy.
- Hypoplastic MDS (cellularity less than 10 percent) or an absolute neutrophil count of less than 200 cells/microL.
- Active malignant disease (excluding non-melanoma skin carcinoma) other than AML.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- An expected survival, in the opinion of the investigator that would not permit a sufficient observation period for evaluating ON 01910.Na.
- HIV positive patients.
- Total bilirubin greater than 1.5 mg/dL not related to hemolysis or Gilbert s disease.
- Serum creatinine greater than 1.5 mg/dL, or a calculated creatinine clearance of less than 60 mL/min/1.73 m(2).
- Ascites requiring active medical management including paracentesis, peripheral bilateral edema, hyponatremia (serum sodium less than 134 meq/L.
- Currently receiving any other investigational agents or concurrent chemotherapy, radiotherapy, or immunotherapy.
- Current pregnancy, unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential or currently breastfeeding. Pregnant and nursing women are excluded from this study.
- Psychiatric illness/social situations that would limit the patient s ability to tolerate and/or comply with study requirements.
- Unable to understand the investigational nature of the study or give informed consent.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike