Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases

Completed · Phase 1

Conditions studied: Accelerated Phase of Disease, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL, Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blastic Phase, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia, Previously Treated Myelodysplastic Syndrome, Primary Myelofibrosis, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Disease, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome

In brief

This phase I trial is studying the side effects and best dose of belinostat when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. 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 belinostat together with azacitidine may kill more cancer cells.

Key facts

Study ID

NCT00351975

Run by

National Cancer Institute (NCI)

People needed

56

Starts

2006-06-01

Expected to finish

2013-03-01

Last updated by the study team

2014-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of 1 of the following:
• Relapsed or refractory acute myeloid leukemia (AML)
• Relapsed or refractory acute promyelocytic leukemia (must have failed both tretinoin and arsenic trioxide)
• Relapsed or refractory acute lymphoblastic leukemia
• Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes (MDS) or myeloproliferative disorders, OR therapy-related AML
• Chronic myelogenous leukemia in accelerated or blast phase
• Advanced phases of Philadelphia chromosome-negative (Ph-) chronic myeloproliferative disorders, as defined by ≥ 1 of the following:
• Presence of anemia (hemoglobin < 10 g/dL and/or red blood cell transfusion dependent)
• Presence of palpable splenomegaly
• MDS, including chronic myelomonocytic leukemia
• Must have intermediate or high-risk International Prognostic Scoring System (IPSS) scores (≥ 0.5)
• Low-risk IPSS scores allowed provided ≥ 1 of the following criteria are met:
• Hemoglobin < 10 g/dL and/or red blood cell transfusion dependent
• Platelet count < 50,000/mm³
• Absolute neutrophil count < 1,000/mm³
• Refractory disease OR no standard therapy exists
• Evidence of AML associated with dysplasia on bone marrow histology for elderly patients (i.e., > 60 years old) who are previously untreated and not candidates for or unwilling to undergoing induction therapy
• No known active CNS involvement with disease
• CALGB performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome)
• ALT ≤ 3 times upper limit of normal (unless due to disease)
• Creatinine ≤ 2 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• University Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada
• Princess Margaret Hospital — Cashmere, Canterbury, New Zealand

Full record on ClinicalTrials.gov

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