Alvespimycin Hydrochloride in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|