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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003681
First received: November 1, 1999
Last updated: May 9, 2009
Last verified: July 2000
  Purpose

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 Intervention Phase
Anemia
Myelodysplastic Syndromes
Biological: epoetin alfa
Drug: amifostine trihydrate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 50
Study Start Date: August 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003681

Locations
Austria
Universitaetsklinik
Innsbruck, Austria, A-6020
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
A.Z. St. Jan
Brugge, Belgium, 8000
Institut Jules Bordet
Brussels (Bruxelles), Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Czech Republic
University Hospital - Olomouc
Olomouc, Czech Republic, 775 20
Institute of Hematology and Blood Transfusion
Prague, Czech Republic, 128 20
Onkologicka Klinka A Onkologicka Lab
Prague (Praha), Czech Republic, 128 08
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 ZA
Portugal
Hospital Escolar San Joao
Porto, Portugal, 4200
Slovakia
Institute of Hematology & Transfusiology, University Hospital
Bratislava, Slovakia, 81103
Switzerland
University Hospital
Basel, Switzerland, CH-4031
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Roel Willemze, MD, PhD Leiden University Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003681     History of Changes
Other Study ID Numbers: CDR0000066783, EORTC-06975
Study First Received: November 1, 1999
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
anemia

Additional relevant MeSH terms:
Anemia
Myelodysplastic Syndromes
Preleukemia
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Epoetin alfa
Amifostine
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014