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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Unknown status

CT.gov ID

NCT00003681

Collaborator

(none)

Enrollment

Locations

4.2

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Myelodysplastic Syndromes	Biological: epoetin alfa Drug: amifostine trihydrate	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

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 :

Aug 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitaetsklinik	Innsbruck	Austria	A-6020
2	Algemeen Ziekenhuis Middelheim	Antwerp	Belgium	2020
3	A.Z. St. Jan	Brugge	Belgium	8000
4	Institut Jules Bordet	Brussels (Bruxelles)	Belgium	1000
5	Universitair Ziekenhuis Antwerpen	Edegem	Belgium	B-2650
6	University Hospital - Olomouc	Olomouc	Czech Republic	775 20
7	Onkologicka Klinka A Onkologicka Lab	Prague (Praha)	Czech Republic	128 08
8	Institute of Hematology and Blood Transfusion	Prague	Czech Republic	128 20
9	Leiden University Medical Center	Leiden	Netherlands	2300 ZA
10	Hospital Escolar San Joao	Porto	Portugal	4200
11	Institute of Hematology & Transfusiology, University Hospital	Bratislava	Slovakia	81103
12	University Hospital	Basel	Switzerland	CH-4031