Status and phase
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About
This phase I trial is studying the side effects and best dose of decitabine and FR901228 in treating patients with relapsed or refractory leukemia, myelodysplastic syndromes or myeloproliferative disorders. Drugs used in chemotherapy, such as decitabine and FR901228, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving decitabine together with FR901228 may kill more cancer cells.
Full description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of decitabine and FR901228 (depsipeptide) in patients with relapsed or refractory leukemia, myelodysplastic syndromes, or myeloproliferative disease.
II. Determine the safety and tolerability of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 and FR901228 (depsipeptide) IV over 4 hours on days 5 and 12 OR days 5, 12, and 19. Treatment repeats every 4-6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing complete remission for 1 year are removed from the study.
Cohorts of 6 patients receive escalating doses of decitabine and FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Enrollment
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia
Acute lymphoblastic leukemia
Chronic myelogenous leukemia (CML)
Myelodysplastic syndromes
Myeloproliferative disease
Chronic lymphocytic leukemia
Acute promyelocytic leukemia
Chronic myelomonocytic leukemia
Relapsed or refractory disease
No known brain or meningeal disease
PATIENT CHARACTERISTICS:
Age
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Hepatic
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Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Other
No concurrent agents that cause QTc prolongation
No other concurrent investigational or commercial agents or therapies for the malignancy
No concurrent hydrochlorothiazide
Primary purpose
Allocation
Interventional model
Masking
36 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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