Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019708
Status:
TERMINATED
Last Update Posted:
2013-12-16
First Post:
2001-07-11
Brief Title:
Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I and Pharmacologic Study of 17-Allylamino-17-Demethoxygeldanamycin AAG NSC 330507 in Adult Patients With Solid Tumors
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who have advanced solid tumors or non-Hodgkins lymphoma Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose of geldanamycin analogue AAG in patients with advanced solid tumors
II To determine the toxic effects of this drug in this patient population III To determine the biochemical and molecular effects of this drug in normal and accessible tumor tissue in these patients
IV To determine the pharmacokinetics of this drug in these patients V To assess any antitumor activity of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive geldanamycin analogue AAG IV over 1-6 hours once daily on days 1 4 15 and 18 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 10 patients are treated at the MTD
Patients are followed every 6 weeks
I To determine the maximum tolerated dose of geldanamycin analogue AAG in patients with advanced solid tumors
II To determine the toxic effects of this drug in this patient population III To determine the biochemical and molecular effects of this drug in normal and accessible tumor tissue in these patients
IV To determine the pharmacokinetics of this drug in these patients V To assess any antitumor activity of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive geldanamycin analogue AAG IV over 1-6 hours once daily on days 1 4 15 and 18 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 10 patients are treated at the MTD
Patients are followed every 6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| T98-0075 | OTHER | CTEP | None |
| NCI-2009-00819 | REGISTRY | None | None |
| UNMC 170-04 | None | None | None |
| CDR0000066965 | None | None | None |
| UNMC 170-04 | OTHER | None | None |