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Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome

NCT ID: NCT00003123

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-08-31

Brief Summary

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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

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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.

Conditions

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Myelodysplastic Syndromes

Keywords

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refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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amifostine trihydrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Providence Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Howard R. Terebelo, DO

Role: STUDY_CHAIR

Providence Hospital

Locations

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Osteopathic Medical Oncology and Hematology, P.C.

Clinton Township, Michigan, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Garden City Hospital

Garden City, Michigan, United States

Site Status

Marquette General Hospital

Marquette, Michigan, United States

Site Status

Providence Hospital Cancer Center

Southfield, Michigan, United States

Site Status

Cleveland Clinic Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

Other Identifiers

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PH-890

Identifier Type: -

Identifier Source: secondary_id

ALZA-97-018-ii

Identifier Type: -

Identifier Source: secondary_id

NCI-V97-1350

Identifier Type: -

Identifier Source: secondary_id

CDR0000065882

Identifier Type: -

Identifier Source: org_study_id