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

NCT00003681 | Unknown Phase 2

• 2 other identifiers: CDR0000066783EORTC-06975
• Study Type: interventional
• Target: 50
• Locations: 7 countries
• Sites: 12

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.

Conditions

Anemia; Myelodysplastic Syndromes

Keywords

refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; anemia

Interventions

epoetin alfa BIOLOGICAL

amifostine trihydrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (12)

Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

A.Z. St. Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

University Hospital - Olomouc

Olomouc, 775 20, Czechia

Location

Institute of Hematology and Blood Transfusion

Prague, 128 20, Czechia

Location

Onkologicka Klinka A Onkologicka Lab

Prague (Praha), 128 08, Czechia

Location

Leiden University Medical Center

Leiden, 2300 ZA, Netherlands

Location

Hospital Escolar San Joao

Porto, 4200, Portugal

Location

Institute of Hematology & Transfusiology, University Hospital

Bratislava, 81103, Slovakia

Location

University Hospital

Basel, CH-4031, Switzerland

Location

MeSH Terms

Conditions

Anemia; Myelodysplastic Syndromes; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts

Interventions

Epoetin Alfa; Amifostine

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Roel Willemze, MD, PhD

  Leiden University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 4, 2004
• Study Start: August 1, 1998
• Last Updated: May 12, 2009

Record last verified: 2000-07

Locations

PT (1); BE (4); CH (1); CZ (3); AU (1); NL (1); SL (1)