Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelodysplastic Syndromes
Intervention: amifostine trihydrate (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Providence Cancer Institute at Providence Hospital - Southfield Campus Official(s) and/or principal investigator(s):
Howard R. Terebelo, DO, Study Chair, Affiliation: Providence Cancer Institute at Providence Hospital - Southfield Campus
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.
Clinical Details
Official title: A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes
Study design: 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.
Eligibility
Minimum age: 17 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States
Garden City Hospital, Garden City, Michigan 48135, United States
Henry Ford Hospital, Detroit, Michigan 48202, United States
Marquette General Hospital, Marquette, Michigan 49855, United States
Osteopathic Medical Oncology and Hematology, P.C., Clinton Township, Michigan 48038-1657, United States
Providence Hospital Cancer Center, Southfield, Michigan 48075, United States
Cleveland Clinic Cancer Center, Cleveland, Ohio 44195, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1997
Last updated: May 23, 2008
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