Alvespimycin Hydrochloride in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
Summary
RATIONALE: Drugs used in chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and the best dose of alvespimycin hydrochloride in treating patients with relapsed chronic lymphocytic leukemia, small lymphocytic lymphoma, or B-cell prolymphocytic leukemia.
Description
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of alvespimycin hydrochloride in patients with relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL).
- To define the dose-limiting toxicity of this drug in these patients.
Secondary
- To determine the pharmacokinetics of this regimen in these patients.
- To determine the feasibility of measuring pharmacodynamic markers of this regimen, including the Hsp90 client proteins Akt and IKK-α/IKK-β.
- To determine whether FoxD3 and downstream genes such as EPHA7 and ID4 are re-expressed in CLL cells following treatment with alvespimycin hydrochloride.
- To correlate pharmacokinetic features of alvespimycin hydrochloride with response, toxicity, and pharmacodynamic endpoints.
- To correlate risk parameters, such as ZAP-70, with response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study followed by an open-label study.
Patients receive alvespimycin hydrochloride IV over 60 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for pharmacokinetic and pharmacodynamic marker studies. Buccal swabs and bone marrow fibroblasts are also collected for DNA extraction and pharmacogenetic analysis.
After completion of study therapy, patients are followed every 3 months for 2 years.
Study Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Leukemia
Intervention
alvespimycin hydrochloride, DNA analysis, laboratory biomarker analysis, pharmacogenomic studies, pharmacological study
Location
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus
Ohio
United States
43210-1240
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01126502
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:34-0400
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Meta-analysis of randomized trials in which estimates of comparative treatment effects are visualized and interpreted from a network of interventions that may or may not have been evaluated directly against each other. Common considerations in network meta-analysis include conceptual and statistical heterogeneity and incoherence.
Biotechnology
Body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing products which are technically, scientifically and clinically useful. Alteration of biologic function at the molecular level (i.e., GENETIC ENGINEERING) is a central focus; laboratory methods used include TRANSFECTION and CLONING technologies, sequence and structure analysis algorithms, computer databases, and gene and protein structure function analysis and prediction.
Small-area Analysis
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