Amifostine With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome
RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome. Epoetin alfa may stimulate red blood cell production and be an effective treatment for anemia in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of amifostine with or without epoetin alfa in treating patients who have myelodysplastic syndrome.
Biological: epoetin alfa
Drug: amifostine trihydrate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia|
|Study Start Date:||August 1998|
OBJECTIVES: I. Compare the effect of amifostine alone and in combination with epoetin alfa on bone marrow progenitor cells and number of blast cells, blood leukocyte counts, reticulocytes, hemoglobin level, and platelet counts as well as peripheral blood and bone marrow blast cell count in patients with myelodysplastic syndromes at a low risk of developing acute leukemia. II. Determine partial or complete response and duration of response in this patient population. III. Characterize the subjective and objective toxicity of amifostine in these patients.
OUTLINE: This is a multicenter study. Patients receive amifostine IV 3 times per week for 3 weeks followed by 1 week of rest. Response is assessed after 2 courses of therapy. Treatment continues in the absence of disease progression. Patients with complete response receive 1 additional course. Patients with partial response or stable disease are stratified into 2 groups: Group 1: Patients with hemoglobin of at least 10 g/dL without transfusion receive 2 additional courses of amifostine alone. Group 2: Patients with hemoglobin less than 10 g/dL, or who are transfusion dependent, receive 2 additional courses of amifostine in combination with epoetin alfa subcutaneously 3 times per week. Both groups are reevaluated after these 2 additional courses. Treatment may then continue at the discretion of the treating physician. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 27-50 patients will be accrued to this study within 1.3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003681
|Innsbruck, Austria, A-6020|
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|A.Z. St. Jan|
|Brugge, Belgium, 8000|
|Institut Jules Bordet|
|Brussels (Bruxelles), Belgium, 1000|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|University Hospital - Olomouc|
|Olomouc, Czech Republic, 775 20|
|Onkologicka Klinka A Onkologicka Lab|
|Prague (Praha), Czech Republic, 128 08|
|Institute of Hematology and Blood Transfusion|
|Prague, Czech Republic, 128 20|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 ZA|
|Hospital Escolar San Joao|
|Porto, Portugal, 4200|
|Institute of Hematology & Transfusiology, University Hospital|
|Bratislava, Slovakia, 81103|
|Basel, Switzerland, CH-4031|
|Study Chair:||Roel Willemze, MD, PhD||Leiden University Medical Center|