Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-16 @ 4:30 AM
Study NCT ID:
NCT01126502
Status:
TERMINATED
Last Update Posted:
2015-11-04
First Post:
2010-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alvespimycin Hydrochloride in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively Complete.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the side effects and the best dose of alvespimycin hydrochloride in treating patients with relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL). 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.
Detailed Description:
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
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.
SECONDARY OBJECTIVES:
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-01374 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| OSU-10021 | None | None | View | |
| CDR0000738867 | None | None | View | |
| OSU 10021 | OTHER | Ohio State University Medical Center | View | |
| 8302 | OTHER | CTEP | View | |
| P30CA016058 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA076576 | NIH | None | https://reporter.nih.gov/quic… | View |