Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Phase I Trial of Fludarabine and Methoxyamine (TRC102) for Relapsed or Refractory Hematologic Malignancies
This phase I trial is studying the side effects and best dose of methoxyamine when given together with fludarabine phosphate in treating patients with relapsed or refractory hematologic malignancies. Drugs used in chemotherapy, such as methoxyamine and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving methoxyamine together with fludarabine phosphate may kill more cancer cells.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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