RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with
OBJECTIVES: I. Define the activity of amifostine in improving blood counts in patients with
OUTLINE: This is an open label, nonrandomized, single center, dose escalation study.
Patients receive amifostine IV for two weeks, followed by 2 weeks of rest. Each treatment
cycle is 4 weeks. Responses are evaluated after each cycle (for a minimum of 2 induction
cycles). Patients with a grade 0 toxicity in the first course receive a 25% increase in dose
during the second course. Patients with grade 1 or 2 toxicity receive no dose change.
Patients with grade 3 toxicity receive a 25% reduction in dose or treatment is stopped. All
patients demonstrating response are eligible for maintenance therapy. Treatment is continued
for up to 12 months or a total of 13 cycles.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued.
DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome Less than 30%
blasts in bone marrow
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Zubrod 0-2 Karnofsky 60-100%
ECOG 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal:
Creatinine no greater than 2 mg/dL Cardiovascular: No New York Heart Association Class IV
disease No antihypertensive medication within 24 hours of amifostine administration Other:
Not pregnant or nursing Effective contraceptive method must be used during study No
medical illness No psychosis Eligible patients with an HLA compatible donor are referred
to bone marrow transplantation
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy within 4 weeks of study and recovered Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified