Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome
|ClinicalTrials.gov Identifier: NCT00003123|
Recruitment Status : Unknown
Verified January 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 12, 2004
Last Update Posted : November 6, 2013
RATIONALE: Amifostine may be effective in helping blood counts return to normal in treating patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: amifostine trihydrate||Phase 2|
OBJECTIVES: I. Determine the overall hematologic response rate to amifostine in patients with advanced myelodysplastic syndrome. II. Determine the toxic effects of amifostine in these patients.
OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes three times a week. Patients failing to respond by 8 weeks undergo dose escalation. Nonresponding patients are removed from the study by 12 weeks. Therapy is continued for up to six months in responding patients. Patients are observed for duration of response upon therapy discontinuation. Patients who relapse will have therapy resumed at the previous dose. Patients will be followed until death.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Official Title:||A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes|
|Study Start Date :||August 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003123
|United States, Michigan|
|Osteopathic Medical Oncology and Hematology, P.C.|
|Clinton Township, Michigan, United States, 48038-1657|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Garden City Hospital|
|Garden City, Michigan, United States, 48135|
|Marquette General Hospital|
|Marquette, Michigan, United States, 49855|
|Providence Hospital Cancer Center|
|Southfield, Michigan, United States, 48075|
|United States, Ohio|
|Cleveland Clinic Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Howard R. Terebelo, DO||Providence Hospital|