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.

Condition	Treatment or Intervention	Phase
Refractory Anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts in transformation refractory anemia with excess blasts	Drug: amifostine	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  17 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Michigan
      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
Ohio
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States

Study chairs or principal investigators

Howard R. Terebelo,  Study Chair,  Providence Hospital Cancer Center   

Study ID Numbers:  CDR0000065882; PH-890; NCI-V97-1350; ALZA-97-018-ii
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003123
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08