Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies
Hematologic Malignancies
About this trial
This is an interventional treatment trial for Hematologic Malignancies focused on measuring Investigational, Chemotherapy, Hematologic Malignancies, Nucleoside analogue
Eligibility Criteria
Patient with relapsed/refractory acute leukemias (AML, ALL, high-grade myelodysplastic syndromes, CMML in transformation with >/= 10% peripheral blood/bone marrow blasts, CML in blast crisis), or patients with relapsed/refractory CLL and an absolute neutrophil count of >/= 1,000/ml and platelet count of >/= 75,000/ml. Signed informed consent indicating that patients are aware of the investigational nature of this study, and in keeping with the policies of this hospital. The only acceptable consent form is attached at the end of this protocol. Age >/= 15 years. ECOG performance status </= 2. No severe, concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for study entry. Pregnant and/or lactating females are not eligible. Normal organ function (serum bilirubin £ 2 mg/dL, serum creatinine £ 2 mg/dL). Patients with renal or liver dysfunction due to organ leukemic involvement may be eligible after discussion with the principle investigator. Patients must be off of all previous chemotherapy, immunotherapy, or radiotherapy for at least 2 weeks prior to entering this study, and must have recovered from all toxic effects, unless life-threatening increases in tumor burden occur.
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Tezacitabine
Tezacitabine as a bolus infusion daily x 5