Amifostine in Treating Patients With Myelodysplastic Syndrome

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Myelodysplastic Syndromes

Treatments: Drug: Amifostine Trihydrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003048

ALZA-97-007-ii

P30CA016672 (U.S. NIH Grant/Contract)

CDR0000065687 (Registry Identifier)

NCI-V97-1300

ALZA-MDA-DM-97-041

DM97-041

MDA-DM-97-041 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Amifostine

Experimental group

Description:

Amifostine IV 2 weeks, followed by 2 weeks rest (4 week cycle)

Treatment:

Drug: Amifostine Trihydrate