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
Clinical Trials
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers relate...
Pazopanib in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery
RATIONALE: Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is stu...
Biomarker Changes in Samples From Young Patients With Acute Myeloid Leukemia
RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn about changes that occur in DNA and identify biomarkers related to c...
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers relate...
S9031-S9126-S9333-S9500-B Biomarker Expression in Patients With Acute Myeloid Leukemia
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer...
PubMed Articles
Pharmacogenomic testing has recently become scalable and available to guide the treatment of major depressive disorder (MDD). The objective of the current meta-analysis was to determine if guidance fr...
A meta-analysis of microRNA-17 as a potential biomarker in diagnosis of colorectal cancer.
This meta-analysis was aimed to determine the diagnostic accuracy of circulating microRNA-17 for colorectal Cancer (CRC). Databases including PubMed, Embase, Web of Science, Cochrane Library and China...
Recent studies have reported the importance of tubulin alpha 4b (TUBA4B), a long non-coding RNA, in the development of several cancers; however, studies on its clinical significance are rare. In the p...
Two structural isomers of cefotiam in cefotiam hydrochloride for injection were observed, and the structures of the isomers were determined by mass spectrometry and various 1D and 2D NMR techniques. T...
Owing to the advantages of transient, broadband, low-energy, transmission and high frequency accuracy, terahertz frequency domain spectroscopy (THz-FDS) has been introduced and pioneered for determini...
Medical and Biotech [MESH] Definitions
Meta-analysis
Works consisting of studies using a quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc. It is often an overview of clinical trials. It is usually called a meta-analysis by the author or sponsoring body and should be differentiated from reviews of literature.
Activation Analysis
A method of chemical analysis based on the detection of characteristic radionuclides following a nuclear bombardment. It is also known as radioactivity analysis. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
Network Meta-analysis
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
A method of analyzing the variation in utilization of health care in small geographic or demographic areas. It often studies, for example, the usage rates for a given service or procedure in several small areas, documenting the variation among the areas. By comparing high- and low-use areas, the analysis attempts to determine whether there is a pattern to such use and to identify variables that are associated with and contribute to the variation.
