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

Alternate Title

Treatment for Cytopenia in Patients With Myelodysplastic Syndrome

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 21 and over Pharmaceutical / Industry BOSTON-VAMC-523 ALZA-97-047-ii, NCI-V98-1422

Objectives

I.  Compare the efficacy of pentoxifylline, ciprofloxacin, and dexamethasone 
to that of amifostine in improving cytopenias of patients with myelodysplastic 
syndromes, specifically refractory anemia and refractory anemia with ringed 
sideroblasts. 

Entry Criteria

Disease Characteristics:

Histologically confirmed myelodysplastic syndromes of the following subtypes:
  Refractory anemia
  Refractory anemia with ringed sideroblasts

Must meet at least one of the following:
 Anemia:  Hemoglobin no greater than 8 g/dL or history of transfusion
  dependence for at least 3 months
 Thrombocytopenia:  Platelet count no greater than 30,000/mm3 or history of
  platelet transfusion dependency for a period of no less than 1 month
 Neutropenia:  Absolute neutrophil count no greater than 1,000/mm3

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior amifostine

Endocrine therapy:
 At least 3 months since prior glucocorticoid therapy

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 At least 24 hours since prior antihypertensive medications

Patient Characteristics:

Age:
 21 and over

Performance status:
 Not specified

Life expectancy:
 At least 6 months

Hematopoietic:
 See Disease Characteristics

Hepatic:
 SGOT/SGPT less than 3 times upper limits of normal

Renal:
 BUN no greater than 40 mg/dL
 Creatinine no greater than 1.5 mg/dL

Cardiovascular:
 No clinically significant cardiac disease, including congestive heart failure

Other:
 Not pregnant or nursing
 Effective contraception required of all fertile patients

Expected Enrollment

A total of 108 patients (54 in each arm) will be accrued into this study.

Outline

This is a randomized, cross over study.

Patients are randomized to receive either pentoxifylline, ciprofloxacin, and 
dexamethasone or amifostine.  If there is no response to treatment, patients 
cross over to the alternative therapy.

Arm I patients receive oral pentoxifylline three times a day for 16 weeks, 
ciprofloxacin twice a day beginning on day 8 and continuing for 16 weeks, and 
dexamethasone every day beginning on day 1 and continuing for 6 weeks, and 
then every other day for 10 weeks.  Arm I maintenance therapy consists of 
pentoxifylline three times a day, ciprofloxacin twice a day, and dexamethasone 
every day for days 1-5 monthly for up to 9 months. 

Arm II patients receive amifostine IV three times a week for 16 weeks.  Arm II 
maintenance therapy consists of amifostine IV twice a week for 12 weeks and 
weekly thereafter for up to 9 months.

Patients are followed every 3 weeks.

Trial Contact Information

Trial Lead Organizations

Veterans Affairs Medical Center - Boston - Jamaica Plain

Louis D. Fiore, MD, Protocol chair		Ph: 617-232-9500