A Phase 2 interventional study of amifostine trihydrate and azacitidine in Myelodysplastic Syndromes, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-21.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Amifostine may improve blood counts in patients with myelodysplastic syndrome. Combining azacitidine with amifostine may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of azacitidine plus amifostine in treating patients who have myelodysplastic syndrome.
OBJECTIVES: I. Determine the response rate to azacitidine plus amifostine in patients with myelodysplastic syndromes. II. Evaluate the toxicity of this treatment regimen in these patients. III. Assess the rate of progression to acute myeloid leukemia and overall survival in these patients treated with this regimen. IV. Evaluate the relationship between response status and cytogenetics, FAB class, ras mutations, and the presence of nonclonal hematopoiesis with this treatment regimen in these patients. V. Assess the effect of this treatment regimen on the number of bone marrow hematopoietic progenitor cells in these patients. VI. Evaluate neutrophil adhesion and chemotaxis in these patients before and after this treatment regimen.
OUTLINE: Patients receive amifostine IV over 1-3 minutes on days 8, 10, 12, 15, 17, 19, 22, 24, and 26 plus azacitidine subcutaneously on days 1-7. Treatment repeats every 28 days for 4 courses. Patients who achieve complete remission receive an additional 3 courses, and patients who achieve hematologic improvement or partial remission continue treatment until disease progression or unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study within approximately 2 years.
2,165 studies on the registry are indexed under Myelodysplastic Syndromes; 322 are open to participants now.
Browse Myelodysplastic Syndromes studies →University of Michigan Rogel Cancer Center is the lead sponsor of 322 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
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DISEASE CHARACTERISTICS: Cytologically confirmed myelodysplastic syndrome (MDS) Intermediate 1, 2, or high risk disease OR Low risk disease with one of the following: Symptomatic anemia requiring transfusion for at least 3 months prior to study Symptomatic thrombocytopenia requiring platelet transfusion Platelet count less than 50,000/mm3 Absolute neutrophil count less than 1,000/mm3 with an infection Stable disease for 1 month with no progression to acute myeloid leukemia Declined or not eligible for allogeneic bone marrow transplant (alloBMT) No prior treatment of MDS with chemotherapy or alloBMT No prior leukemia or more than 30% myeloblasts in the bone marrow
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: 0-2 Life expectancy: Greater than 4 months Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5 times normal (unless due to hemolysis or ineffective erythropoiesis) AST and ALT less than 2 times normal Renal: Creatinine less than 1.5 times normal Cardiovascular: No uncontrolled or severe congestive heart failure Pulmonary: Serum CO2 greater than 18 mmHg Other: No uncorrected folate or vitamin B12 deficiency HIV negative No other medical or psychiatric illness that would preclude study At least 3 years since prior nonleukemic malignancy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month since prior interferon, interleukin-3, or interleukin-11 At least 1 month since prior epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) No concurrent hematologic growth factors Chemotherapy: See Disease Characteristics Prior chemotherapy for nonleukemic malignancy allowed No prior azacitidine Endocrine therapy: At least 1 month since prior corticosteroids or danazol No concurrent steroids Radiotherapy: Prior radiotherapy for nonleukemic malignancy allowed Surgery: Not specified Other: No prior antithymocyte globulin or cyclosporine No prior amifostine
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azacitidine
University of Michigan Rogel Cancer Center →