Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia
18 Years
N/A
Both
Anemia, Myelodysplastic Syndromes
Trial Information
Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Roel Willemze, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Leiden University Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000066783
NCT ID:
NCT00003681
Start Date:
August 1998
Completion Date:
Related Keywords:
- Anemia
- Myelodysplastic Syndromes
- refractory anemia
- refractory anemia with ringed sideroblasts
- refractory anemia with excess blasts
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- anemia
- Anemia
- Myelodysplastic Syndromes
- Preleukemia
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