Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004241
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2000-01-28
Brief Title:
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer Malignant Lymphoma or Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial cancer malignant lymphoma or sarcoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in patients with advanced epithelial cancer malignant lymphoma or sarcoma
II Determine the significant toxic effects associated with this drug in these patients
III Determine the response in patients treated with this drug IV Determine the pharmacokinetics of 17-AAG and 17AG in these patients
OUTLINE This is a dose-escalation study Patients receive treatment according to 1 of 2 schedules
Schedule B Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 1-2 hours twice weekly for 3 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Schedule C Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
In both schedules cohorts of 3-6 patients receive escalating doses of 17-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 At least 6 patients receive treatment at the MTD
PROJECTED ACCRUAL A maximum of 60 patients will be accrued for this study
I Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in patients with advanced epithelial cancer malignant lymphoma or sarcoma
II Determine the significant toxic effects associated with this drug in these patients
III Determine the response in patients treated with this drug IV Determine the pharmacokinetics of 17-AAG and 17AG in these patients
OUTLINE This is a dose-escalation study Patients receive treatment according to 1 of 2 schedules
Schedule B Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 1-2 hours twice weekly for 3 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Schedule C Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
In both schedules cohorts of 3-6 patients receive escalating doses of 17-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 At least 6 patients receive treatment at the MTD
PROJECTED ACCRUAL A maximum of 60 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000067486 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA099168 |
| PCI-99-020 | None | None | None |
| U01CA099168 | NIH | None | None |