Amifostine With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia; Myelodysplastic Syndromes
Intervention: amifostine trihydrate (Drug); epoetin alfa (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: European Organization for Research and Treatment of Cancer Official(s) and/or principal investigator(s):
Roel Willemze, MD, PhD, Study Chair, Affiliation: Leiden University Medical Center
Summary
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.
Clinical Details
Official title: Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia
Study design: Treatment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Confirmed diagnosis of good or intermediate prognosis
myelodysplasia of one of the following types: Refractory anemia Refractory anemia with
ringed sideroblasts Refractory anemia with excess blasts with no greater than 10% bone
marrow blasts No complex abnormalities or involvement of chromosome 7
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Hemoglobin no greater than 10 g/dL OR Transfusion requirement
of at least 2 packs RBC per month AND/OR Platelet count no greater than 50,000/mm3 AND/OR
Neutrophil count no greater than 1,000/mm3 Hepatic: Bilirubin no greater than 2. 5 times
upper limit of normal (ULN) SGPT/ALT no greater than 2. 5 times ULN Renal: Creatinine no
greater than 1. 5 times ULN Cardiovascular: No severe cardiac dysfunction (CTC-NCIC grade
III or IV) Pulmonary: No severe pulmonary dysfunction Neurologic: No history of CNS
disturbances Other: No current or recent history of allergies No other nonmalignant
systemic disease Not pregnant or nursing No active uncontrolled infections Must have
cytogenetics done within the past 4 months
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 months since prior growth factors or
biological response modifiers for myelodysplastic syndrome except for supportive care No
other concurrent hematopoietic growth factors Chemotherapy: At least 2 months since other
prior chemotherapy for myelodysplastic syndrome Endocrine therapy: No concurrent
glucocorticoids No concurrent androgens Radiotherapy: Not specified Surgery: Not specified
Other: No concurrent vitamin A or D derivatives
Locations and Contacts
Universitaetsklinik, Innsbruck A-6020, Austria
A.Z. St. Jan, Brugge 8000, Belgium
Algemeen Ziekenhuis Middelheim, Antwerp 2020, Belgium
Institut Jules Bordet, Brussels (Bruxelles) 1000, Belgium
Universitair Ziekenhuis Antwerpen, Edegem B-2650, Belgium
Institute of Hematology and Blood Transfusion, Prague 128 20, Czech Republic
Onkologicka Klinka A Onkologicka Lab, Prague (Praha) 128 08, Czech Republic
University Hospital - Olomouc, Olomouc 775 20, Czech Republic
Leiden University Medical Center, Leiden 2300 ZA, Netherlands
Hospital Escolar San Joao, Porto 4200, Portugal
Institute of Hematology & Transfusiology, University Hospital, Bratislava 81103, Slovakia
University Hospital, Basel CH-4031, Switzerland
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1998
Last updated: May 23, 2008
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