Alvespimycin Hydrochloride in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT01126502|
Recruitment Status : Terminated (Administratively Complete.)
First Posted : May 19, 2010
Last Update Posted : November 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|B-cell Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia||Drug: alvespimycin hydrochloride Other: diagnostic laboratory biomarker analysis Other: pharmacogenomic studies Other: pharmacological study||Phase 1|
I. To determine the maximum tolerated dose (MTD) of 17-DMAG in patients with relapsed CLL/SLL and B-PLL.
II. To define the dose limiting toxicity (DLT) of 17-DMAG in patients with relapsed CLL/SLL and B-PLL.
I. To assess preliminary efficacy of 17-DMAG in patients with relapsed CLL/SLL and B-PLL.
II. To determine the pharmacokinetics of 17-DMAG in patients with relapsed CLL/SLL and B-PLL.
III. To determine the feasibility of measuring pharmacodynamic markers of 17-DMAG including the Hsp90 client proteins Akt and IKK-alpha/IKK-beta.
IV. To determine if FoxD3 and downstream genes such as EPHA7 and ID4 are re-expressed in CLL cells following treatment with 17-DMAG.
V. To correlate pharmacokinetic features of 17-DMAG with response, toxicity and pharmacodynamic endpoints.
VI. To correlate risk parameters such as ZAP-70 with response to 17-DMAG.
OUTLINE: This is a dose-escalation study.
Patients receive alvespimycin hydrochloride intravenously (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.
After completion of study therapy, patients are followed every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Hsp90 Inhibitor 17-DMAG (Alvespimycin) in Patients With Relapsed Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), and B-cell Prolymphocytic Leukemia (B-PLL)|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Treatment (enzyme inhibitor therapy)
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.
Drug: alvespimycin hydrochloride
Other: diagnostic laboratory biomarker analysis
Other: pharmacogenomic studies
Other Name: Pharmacogenomic Study
Other: pharmacological study
Other Name: pharmacological studies
- Maximum tolerated dose of 17-DMAG [ Time Frame: 21 days ]Defined as the maximum dose level where at most 1 of 6 patients experience dose-limiting toxicity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126502
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Jeffrey Jones||Ohio State University|