Phase II Study of Fludarabine, Carboplatin, and Topotecan With Thalidomide for Patients With Relapsed/Refractory or High Risk Acute Myelogenous Leukemia, Chronic Myeloid Leukemia and Advanced Myelodysplastic Syndromes
- Determine the response rate of patients with relapsed/refractory or high-risk acute
myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes
treated with fludarabine, carboplatin, topotecan, and thalidomide.
- Determine the non-hematologic toxicity profile and time to hematopoietic recovery in
patients treated with this regimen.
- Determine the effects of this regimen on changes in biologic parameters that may
predict response in these patients.
- Correlate bone marrow microvascular density before and after treatment with response in
- Determine the prognostic value of pretreatment plasma and serum levels of vascular
endothelial growth factor (VEGF) and/or the modulation of serum levels of VEGF during
treatment in predicting response in these patients.
OUTLINE: Patients are stratified according to diagnosis (previously untreated acute leukemia
Patients receive fludarabine IV over 5-10 minutes and carboplatin IV over 24 hours on days
1-5 followed by topotecan IV continuously over 72 hours. Patients receive oral thalidomide
daily beginning within days 1-3 and continuing in the absence of disease progression or
Patients with residual disease on day 16-18 may receive a second course of chemotherapy as
above. Patients who achieve remission may receive a third course of chemotherapy as above as
consolidation beginning 4-8 weeks after completion of prior chemotherapy.
Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
6 weeks after treatment
Brenda W. Cooper, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|