Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096005
Status:
TERMINATED
Last Update Posted:
2014-02-24
First Post:
2004-11-09
Brief Title:
Tanespimycin and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of 17-Allylaminogeldanamycin 17-AAG And PS341 In Advanced Malignancies
Status:
TERMINATED
Status Verified Date:
2011-10
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 giving tanespimycin together with bortezomib in treating patients with advanced solid tumors or lymphomas Accrual for lymphoma patients closed as of 112709 Drugs used in chemotherapy such as tanespimycin work in different ways to stop cancer cells from dividing so they stop growing or die Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth It may also increase the effectiveness of tanespimycin by making cancer cells more sensitive to the drug Combining tanespimycin with bortezomib may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG tanespimycin and bortezomib in patients with advanced solid tumors or lymphomas Accrual for Lymphoma Patients Closed as of 112709
II Determine changes in biomarkers eg HSP70 client proteins and ubiquitination of proteins in peripheral blood mononuclear cells and tumor specimens from patients with advanced solid tumors or lymphomas Accrual for Lymphoma Patients Closed as of 112709 treated with this regimen
III Determine responses in patients treated with this regimen IV Determine the toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive tanespimycin intravenously IV over 1-2 hours and bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of tanespimycin and bortezomib 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 dose-limiting toxicity Once the MTD is determined at least 12 additional patients are treated as above at the MTD
NOTE Bortezomib is not administered on day 1 of course 1 only Patients are followed at 3 months
I Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG tanespimycin and bortezomib in patients with advanced solid tumors or lymphomas Accrual for Lymphoma Patients Closed as of 112709
II Determine changes in biomarkers eg HSP70 client proteins and ubiquitination of proteins in peripheral blood mononuclear cells and tumor specimens from patients with advanced solid tumors or lymphomas Accrual for Lymphoma Patients Closed as of 112709 treated with this regimen
III Determine responses in patients treated with this regimen IV Determine the toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive tanespimycin intravenously IV over 1-2 hours and bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of tanespimycin and bortezomib 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 dose-limiting toxicity Once the MTD is determined at least 12 additional patients are treated as above at the MTD
NOTE Bortezomib is not administered on day 1 of course 1 only Patients are followed at 3 months
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 |
|---|---|---|---|
| P30CA015083 | NIH | CTEP | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2009-00043 | REGISTRY | None | None |
| MAYO-MC0214 | None | None | None |
| NCI-6121 | None | None | None |
| CDR0000391837 | None | None | None |
| MC0214 | OTHER | None | None |
| 6121 | OTHER | None | None |
| U01CA069912 | NIH | None | None |