Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
16 Years
N/A
Both
Leukemia, Myelodysplastic Syndromes
Trial Information
Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
OBJECTIVES:
- Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with
poor risk myelodysplastic syndrome.
- Determine the hematologic response rate, cytogenetic response rate, and the rate of
polyclonal hematopoiesis following this treatment regimen.
- Determine the duration of response and time to disease progression following this
treatment regimen in these patients.
OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2
hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a
maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after
the first.
Patients are followed at least monthly for 2 years, then every 3-6 months until death.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5
years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed poor risk myelodysplastic syndrome, including at least one
of the following:
- Bilineage cytopenia
- Unfavorable cytogenetic abnormalities
- Refractory anemia with excess blasts and/or refractory anemia with excess blast
in transformation (greater than 5% blast)
- At least 0.5 on the International Prognostic Score System
- No chronic myelomonocytic leukemia
- No hypocellular myelodysplastic syndrome (marrow cellularity less than 30%)
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count less than 1,500/mm3
- Platelet count less than 100,000/mm3
- Hemoglobin less than 10 g/dL
Hepatic:
- ALT less than 5 times upper limit of normal
Renal:
- Creatinine no greater than 1.4 mg/dL
Cardiovascular:
- No congestive heart failure
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Must have right atrial catheter inserted
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior blood or bone marrow transplantations
Chemotherapy:
- No prior acute myeloid leukemia chemotherapy (except hydroxyurea or low dose
cytarabine)
- No prior topotecan
- No prior amifostine
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 24 hours since prior antihypertensive medication prior to amifostine
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Henry C. Fung, MD, FRCPE
Investigator Role:
Study Chair
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000066982
NCT ID:
NCT00003827
Start Date:
January 1999
Completion Date:
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- refractory anemia with excess blasts
- refractory anemia with excess blasts in transformation
- de novo myelodysplastic syndromes
- secondary myelodysplastic syndromes
- childhood myelodysplastic syndromes
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
