Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089271
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2004-08-04
Brief Title:
17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin 17-DMAG NSC 707545 In Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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 17-DMAG in treating patients with metastatic or unresectable solid tumors or lymphomas Drugs used in chemotherapy such as 17-DMAG work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in patients with metastatic or unresectable solid tumors or lymphomas
II Determine the safety and toxicity of this drug in these patients III Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
IV Determine the recommended phase II dose of this drug for future studies
SECONDARY OBJECTIVES
I Determine tumor response in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG IV over 1-6 hours on days 1-3 or 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 1-2 patients receive accelerated escalating doses of 17-DMAG 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 17-DMAG 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
Patients are followed at 4 weeks
I Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in patients with metastatic or unresectable solid tumors or lymphomas
II Determine the safety and toxicity of this drug in these patients III Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
IV Determine the recommended phase II dose of this drug for future studies
SECONDARY OBJECTIVES
I Determine tumor response in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG IV over 1-6 hours on days 1-3 or 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 1-2 patients receive accelerated escalating doses of 17-DMAG 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 17-DMAG 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
Patients are followed at 4 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 |
|---|---|---|---|
| CDR0000378189 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062502 |
| PCI-03-153 | None | None | None |
| U01CA069912 | NIH | None | None |
| U01CA099168 | NIH | None | None |
| U01CA062502 | NIH | None | None |