A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes
17 Years
N/A
Both
Myelodysplastic Syndromes
Trial Information
A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Howard R. Terebelo, DO
Investigator Role:
Study Chair
Investigator Affiliation:
Providence Cancer Institute at Providence Hospital - Southfield Campus
Authority:
United States: Federal Government
Study ID:
CDR0000065882
NCT ID:
NCT00003123
Start Date:
August 1997
Completion Date:
Related Keywords:
- Myelodysplastic Syndromes
- refractory anemia
- refractory anemia with ringed sideroblasts
- refractory anemia with excess blasts
- refractory anemia with excess blasts in transformation
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Marquette General Hospital | Marquette, Michigan 49855 |
| Osteopathic Medical Oncology and Hematology, P.C. | Clinton Township, Michigan 48038-1657 |
| Garden City Hospital | Garden City, Michigan 48135 |
| Providence Hospital Cancer Center | Southfield, Michigan 48075 |
