- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003123
Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome
A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Clinton Township, Michigan, United States, 48038-1657
- Osteopathic Medical Oncology and Hematology, P.C.
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Garden City, Michigan, United States, 48135
- Garden City Hospital
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Marquette, Michigan, United States, 49855
- Marquette General Hospital
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Southfield, Michigan, United States, 48075
- Providence Hospital Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven advanced myelodysplastic syndrome (MDS), including: Refractory anemia Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation MDS with at least bicytopenia No chronic myelomonocytic leukemia No acute leukemia
PATIENT CHARACTERISTICS: Age: 17 and over Performance Status: ECOG 0-2 Life Expectancy: Greater than 6 months Hematopoietic: Hemoglobin less than 8.5 g/dL Absolute granulocyte count less than 1,000 g/dL Platelet count less than 70,000/mm3 Hepatic: No major hepatic problems Renal: No major renal problems Cardiovascular: No major cardiac disease Other: Prior transfusion of blood products is allowed Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior cytokine therapy is allowed Chemotherapy: No prior chemotherapy Endocrine therapy: Prior steroid therapy is allowed Radiotherapy: Not specified Surgery: Not specified Other: Prior leucovorin calcium and pyridoxine allowed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Howard R. Terebelo, DO, Providence Hospital
Publications and helpful links
General Publications
- Terebelo H, Marsico D, Shurafa M, et al.: A phase II trial of amifostine in patients with advanced myelodysplastic syndromes. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A82, 23a, 1999.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000065882
- PH-890
- ALZA-97-018-ii
- NCI-V97-1350
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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