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 myelodysplastic syndrome.

Condition	Treatment or Intervention	Phase
Previously Treated Myelodysplastic Syndrome secondary myelodysplastic syndrome de novo myelodysplastic syndrome	Drug: amifostine	Phase II

Further Study Details: 

OBJECTIVES: I. Define the activity of amifostine in improving blood counts in patients with myelodysplastic syndrome.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics--

• Histologically proven myelodysplastic syndrome; Less than 30% blasts in bone marrow

--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

--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

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Razelle Kurzrock,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000065687; MDA-DM-97-041; NCI-V97-1300; ALZA-97-007-ii; ALZA-MDA-DM-97-041
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003048
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08