Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome
- Conditions
- Myelodysplastic Syndromes
- Registration Number
- NCT00003123
- Lead Sponsor
- Providence Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
Osteopathic Medical Oncology and Hematology, P.C.
🇺🇸Clinton Township, Michigan, United States
Garden City Hospital
🇺🇸Garden City, Michigan, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Providence Hospital Cancer Center
🇺🇸Southfield, Michigan, United States