Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	17 and over	Pharmaceutical / Industry	PH-890 ALZA-97-018-ii, NCI-V97-1350, NCT00003123

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.

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

Expected Enrollment

A maximum of 36 patients will be accrued.

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.

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.

Trial Contact Information

Trial Lead Organizations

Providence Cancer Institute at Providence Hospital - Southfield Campus

Howard Terebelo, DO, Protocol chair		Ph: 248-552-0620; 800-341-0801 Email: hiccup@comcast.net

Registry Information
Official Title		A Phase II Trial of Ethyol (Amifostine) in Adult Patients with Advanced Myelodysplastic Syndromes
Trial Start Date		1997-08-01
Registered in ClinicalTrials.gov		NCT00003123
Date Submitted to PDQ		1997-10-27
Information Last Verified		2004-01-20

Back to Top