Amifostine With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome

Anemia Clinical Trial

Official title:

Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003681
• Other study ID #: CDR0000066783
• Secondary ID: EORTC-06975
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: May 9, 2009
• Start date: August 1998

Study information

• Verified date: July 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Biological:
• epoetin alfa

Drug:
• amifostine trihydrate

Locations

Country	Name	City	State
Austria	Universitaetsklinik	Innsbruck
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	A.Z. St. Jan	Brugge
Belgium	Institut Jules Bordet	Brussels (Bruxelles)
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Czech Republic	University Hospital - Olomouc	Olomouc
Czech Republic	Institute of Hematology and Blood Transfusion	Prague
Czech Republic	Onkologicka Klinka A Onkologicka Lab	Prague (Praha)
Netherlands	Leiden University Medical Center	Leiden
Portugal	Hospital Escolar San Joao	Porto
Slovakia	Institute of Hematology & Transfusiology, University Hospital	Bratislava
Switzerland	University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Netherlands,  Portugal,  Slovakia,  Switzerland,