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


Phase 2
17 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard R. Terebelo, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Providence Cancer Institute at Providence Hospital - Southfield Campus

Authority:

United States: Federal Government

Study ID:

CDR0000065882

NCT ID:

NCT00003123

Start Date:

August 1997

Completion Date:

Related Keywords:

  • Myelodysplastic Syndromes
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Henry Ford HospitalDetroit, Michigan  48202
Marquette General HospitalMarquette, Michigan  49855
Osteopathic Medical Oncology and Hematology, P.C.Clinton Township, Michigan  48038-1657
Garden City HospitalGarden City, Michigan  48135
Providence Hospital Cancer CenterSouthfield, Michigan  48075