Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	18 and over		EORTC-06975 NCT00003681

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.

Entry 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

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

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

Expected Enrollment

A total of 27-50 patients will be accrued to this study within 1.3 years.

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Roel Willemze, MD, PhD, Protocol chair		Ph: 31-71-526-2267 Email: R.Willemze@lumc.nl

Registry Information
Official Title		Phase II Multicenter Study of Amifostine in Patients with Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia
Trial Start Date		1998-08-25
Registered in ClinicalTrials.gov		NCT00003681
Date Submitted to PDQ		1998-12-01
Information Last Verified		2000-07-01

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