MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
Completed · Phase 1
Conditions studied: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Leukemia, Myelodysplastic Syndrome, Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome
In brief
MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving MS-275 together with azacitidine may kill more cancer cells. This phase I trial is studying the side effects and best dose of MS-275 when given together with azacitidine in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
Key facts
- Study ID
- NCT00101179
- Run by
- National Cancer Institute (NCI)
- People needed
- 63
- Starts
- 2004-11-03
- Expected to finish
- 2014-02-03
- Last updated by the study team
- 2019-10-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of 1 of the following:
- Histologically confirmed myelodysplastic syndromes (MDS) by bone marrow aspiration and/or biopsy
- International Prognostic Scoring System (IPSS) score of intermediate-1, intermediate-2, or high
- International Prognostic Scoring System (IPSS) score of intermediate-1, intermediate-2, or high
- Low IPSS score allowed provided patient has a clinically significant cytopenia (i.e., absolute neutrophil count < 1,000/mm\^3, untransfused hemoglobin < 8 g/dL, platelet count < 20,000/mm\^3, or anemia requiring transfusion)
- Chronic myelomonocytic leukemia
- Acute myeloid leukemia (AML)
- Relapsed or refractory disease
- Untreated AML allowed provided patient meets >= 1 of the following criteria:
- Age 60 and over
- AML arising in the setting of an antecedent hematologic disorder
- High-risk cytogenetic abnormalities
- Medical conditions that may compromise the ability to give cytotoxic chemotherapy as the primary modality
- Refused cytotoxic chemotherapy
- WBC < 30,000/mm3 for >= 2 weeks before study entry
- Acute promyelocytic leukemia allowed provided patient is in at least second relapse and has already received treatment regimens containing arsenic trioxide and isotretinoin
- No clinical evidence of CNS or pulmonary leukostasis or CNS leukemia
- Peformance status:
- Zubrod 0-2
- Life expectancy:
- At least 6 months
- Hematopoietic:
- See Disease Characteristics
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
- No disseminated intravascular coagulation
Where it is running
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
- Mount Sinai Hospital — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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