Clinical trial NCT00003123: Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome
Official title: A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-12
Enrollment: 36
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clinton Township
country: United States
facility: Osteopathic Medical Oncology and Hematology, P.C.
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Garden City
country: United States
facility: Garden City Hospital
state: Michigan
city: Marquette
country: United States
facility: Marquette General Hospital
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital Cancer Center
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center
state: Ohio
Study officials:
affiliation: Providence Hospital
name: Howard R. Terebelo, DO
role: STUDY_CHAIR
References:
citation: 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.