Phase I Trial of Sequential Topotecan(NSC 609699)and Etoposide for Patients With Relapsed, Refractory,or High Risk Acute Myeloid or Lymphoid Leukemia
OBJECTIVES: I. Determine the maximum tolerated dose of topotecan when combined with
etoposide in patients with relapsed or refractory acute myelogenous leukemia, acute
lymphoblastic leukemia, or blastic phase chronic myelogenous leukemia. II. Determine the
toxicity of this regimen in these patients. III. Measure serum levels of topotecan at steady
state and correlate them with any change in topoisomerase II content in leukemic blasts. IV.
Assess whether it is feasible to correlate any upregulation of topoisomerase II expression
with tumor response to etoposide in subsequent Phase II studies. V. Assess whether levels of
pretreatment expression of topoisomerases I and II in leukemic cells are predictive of
clinical response. VI. Assess whether it is feasible to develop a pharmacodynamic assay
based on posttreatment apoptotic changes in leukemic blasts and whether this could be
correlated with tumor response in subsequent phase II trials. VII. Determine the response in
patients treated with this regimen.
OUTLINE: Induction: 2-Drug Combination Chemotherapy. Topotecan, TOPO, NSC-609699; Etoposide,
VP-16, NSC-141540. Consolidation: 2-Drug Combination Chemotherapy. TOPO; VP-16.
PROJECTED ACCRUAL: 15-23 patients will be accrued in approximately 18 months.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose of topotecan when combined with etoposide in patients with relapsed or refractory acute myelogenous leukemia, acute lymphoblastic leukemia, or blastic phase chronic myelogenous leukemia.
Yes
Brenda W. Cooper, MD
Study Chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU2994
NCT00002588
August 1994
January 2001
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |