Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089362
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2004-08-04
Brief Title:
Alvespimycin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 1 Study of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG NSC 707545 in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-04
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:
This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride in treating patients with metastatic or unresectable solid tumors Drugs used in chemotherapy such as alvespimycin hydrochloride work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the toxic effects and maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in patients with metastatic or unresectable solid tumors
SECONDARY OBJECTIVES
II Determine the effects of this drug on the expression of Hsp90 client proteins in normal and tumor tissue samples from these patients
OUTLINE This is a dose-escalation study
Patients receive alvespimycin hydrochloride IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-2 patients receive accelerated escalating doses of alvespimycin hydrochloride until at least 1 of 2 patients experience dose-limiting toxicity DLT Cohorts are then expanded to 3-6 patients who receive escalating doses in a standard manner of alvespimycin hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT Once the MTD is determined 10 additional patients are treated at that dose
I Determine the toxic effects and maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in patients with metastatic or unresectable solid tumors
SECONDARY OBJECTIVES
II Determine the effects of this drug on the expression of Hsp90 client proteins in normal and tumor tissue samples from these patients
OUTLINE This is a dose-escalation study
Patients receive alvespimycin hydrochloride IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-2 patients receive accelerated escalating doses of alvespimycin hydrochloride until at least 1 of 2 patients experience dose-limiting toxicity DLT Cohorts are then expanded to 3-6 patients who receive escalating doses in a standard manner of alvespimycin hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT Once the MTD is determined 10 additional patients are treated at that dose
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 |
|---|---|---|---|
| U01CA069856 | NIH | None | httpsreporternihgovquickSearchU01CA069856 |
| 04-053 | None | None | None |
| MSKCC-04053 | None | None | None |
| NCI-6542 | None | None | None |
| CDR0000378288 | None | None | None |