Finding studies
Finding studies
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Lead
Case Comprehensive Cancer Center
With
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of methoxyamine given in conjunction with fludarabine (fludarabine phosphate) in subjects with relapsed or refractory hematologic malignancies. SECONDARY OBJECTIVES: I. To determine the dose limiting toxicities of the combination of methoxyamine and fludarabine. II. To determine the pharmacokinetics of methoxyamine when given in combination with fludarabine. III. To evaluate pharmacodynamic endpoints including apurinic/apyrimidinic (AP) sites and deoxyribonucleic acid (DNA) strand breaks in blood mononuclear cells to explore the in vivo mechanism of action of methoxyamine and identify the biologically optimal dose to be combined with fludarabine. VI. To determine the disease specific toxicity and biologic activity in a cohort of chronic lymphocytic leukemia (CLL) patients. OUTLINE: This is a dose-escalation study of methoxyamine. Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days 1-5 and methoxyamine IV over 1 hour on day 1 (day 2 of course 1). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 1 year.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
