Status:
COMPLETED
MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
OBJECTIVES: I. Determine the safety and toxicity of MS-275 and azacitidine in patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia. II. Determine the m...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Renal:
- Creatinine normal OR
- Creatinine clearance \>= 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study treatment
- No untreated, active infection
- No other serious or uncontrolled medical condition
- More than 3 weeks since prior hematopoietic growth factors for this malignancy
- At least 3 weeks since prior hydroxyurea (2 weeks for AML patients)
- No concurrent hydroxyurea
- Recovered from all prior therapy
- At least 2 weeks since prior cytotoxic therapy (AML patients)
- More than 3 weeks since other prior therapy for this malignancy
- No other concurrent investigational or commercial agents or therapies for this malignancy
- No concurrent valproic acid
- Hepatic:
- Bilirubin normal unless due to hemolysis or Gilbert's syndrome
- AST and ALT =\< 2.5 times upper limit of normal
Exclusion
Key Trial Info
Start Date :
November 3 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2014
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00101179
Start Date
November 3 2004
End Date
February 3 2014
Last Update
October 18 2019
Active Locations (3)
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1
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
2
Mount Sinai Hospital
New York, New York, United States, 10029
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065