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Alvespimycin Hydrochloride in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia

2014-08-27 03:13:34 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:34-0400

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