Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

Official title:

A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003123
• Other study ID #: CDR0000065882
• Secondary ID: PH-890ALZA-97-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: November 5, 2013
• Start date: August 1997

Study information

• Verified date: January 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• amifostine trihydrate

Locations

Country	Name	City	State
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Osteopathic Medical Oncology and Hematology, P.C.	Clinton Township	Michigan
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Garden City Hospital	Garden City	Michigan
United States	Marquette General Hospital	Marquette	Michigan
United States	Providence Hospital Cancer Center	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Providence Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.