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A Phase II Trial of 5-Azacytidine (NSC #102816) and Ethyol (Amifostine) in the Treatment of Adults With Myelodysplastic Syndromes

Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndromes

Thank you

Trial Information

A Phase II Trial of 5-Azacytidine (NSC #102816) and Ethyol (Amifostine) in the Treatment of Adults With Myelodysplastic Syndromes

OBJECTIVES: I. Determine the response rate to azacitidine plus amifostine in patients with
myelodysplastic syndromes. II. Evaluate the toxicity of this treatment regimen in these
patients. III. Assess the rate of progression to acute myeloid leukemia and overall survival
in these patients treated with this regimen. IV. Evaluate the relationship between response
status and cytogenetics, FAB class, ras mutations, and the presence of nonclonal
hematopoiesis with this treatment regimen in these patients. V. Assess the effect of this
treatment regimen on the number of bone marrow hematopoietic progenitor cells in these
patients. VI. Evaluate neutrophil adhesion and chemotaxis in these patients before and after
this treatment regimen.

OUTLINE: Patients receive amifostine IV over 1-3 minutes on days 8, 10, 12, 15, 17, 19, 22,
24, and 26 plus azacitidine subcutaneously on days 1-7. Treatment repeats every 28 days for
4 courses. Patients who achieve complete remission receive an additional 3 courses, and
patients who achieve hematologic improvement or partial remission continue treatment until
disease progression or unacceptable toxicity. Patients are followed until death.

PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study within
approximately 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Cytologically confirmed myelodysplastic syndrome (MDS)
Intermediate 1, 2, or high risk disease OR Low risk disease with one of the following:
Symptomatic anemia requiring transfusion for at least 3 months prior to study Symptomatic
thrombocytopenia requiring platelet transfusion Platelet count less than 50,000/mm3
Absolute neutrophil count less than 1,000/mm3 with an infection Stable disease for 1 month
with no progression to acute myeloid leukemia Declined or not eligible for allogeneic bone
marrow transplant (alloBMT) No prior treatment of MDS with chemotherapy or alloBMT No
prior leukemia or more than 30% myeloblasts in the bone marrow

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: 0-2 Life expectancy: Greater
than 4 months Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5
times normal (unless due to hemolysis or ineffective erythropoiesis) AST and ALT less than
2 times normal Renal: Creatinine less than 1.5 times normal Cardiovascular: No
uncontrolled or severe congestive heart failure Pulmonary: Serum CO2 greater than 18 mmHg
Other: No uncorrected folate or vitamin B12 deficiency HIV negative No other medical or
psychiatric illness that would preclude study At least 3 years since prior nonleukemic
malignancy Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month
since prior interferon, interleukin-3, or interleukin-11 At least 1 month since prior
epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) No concurrent hematologic
growth factors Chemotherapy: See Disease Characteristics Prior chemotherapy for
nonleukemic malignancy allowed No prior azacitidine Endocrine therapy: At least 1 month
since prior corticosteroids or danazol No concurrent steroids Radiotherapy: Prior
radiotherapy for nonleukemic malignancy allowed Surgery: Not specified Other: No prior
antithymocyte globulin or cyclosporine No prior amifostine

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Harry P. Erba, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

March 2002

Related Keywords:

  • Myelodysplastic Syndromes
  • refractory anemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Myelodysplastic Syndromes
  • Preleukemia



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752