Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping
blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining fludarabine, carboplatin,
and topotecan with thalidomide in treating patients who have relapsed or refractory acute
myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes.
OBJECTIVES:
- 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
these patients.
- 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
vs other).
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
unacceptable toxicity.
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
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