Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004075
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
1999-12-10
Brief Title:
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Trial of 17-Allylaminogeldanamycin 17-AAG in Solid Tumor and Lymphoma Patients
Status:
COMPLETED
Status Verified Date:
2011-08
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with solid tumors that cannot be removed by surgery
PURPOSE This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with solid tumors that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG administered at 2 different dosing schedules in patients with unresectable solid tumors
Determine the pharmacokinetics of this drug in these patients
Assess the effect of this drug on heat shock protein chaperone complex components and client proteins in lymphoma tissue obtained pre- and post-treatment in patients with relapsed lymphoma
Determine any response to this drug in these patients
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 2 treatment groups
Group I Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Group II Patients receive 17-AAG IV over 1 hour on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 solid tumor 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
Once the MTD is determined 10 patients with either lymphoma or superficial solid tumors accessible for biopsy are treated as in group II at the MTD
Patients are followed for 3 months
PROJECTED ACCRUAL A total of 58-130 patients 30-72 for group I and 28-58 for group II will be accrued for this study within 2 years
Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG administered at 2 different dosing schedules in patients with unresectable solid tumors
Determine the pharmacokinetics of this drug in these patients
Assess the effect of this drug on heat shock protein chaperone complex components and client proteins in lymphoma tissue obtained pre- and post-treatment in patients with relapsed lymphoma
Determine any response to this drug in these patients
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 2 treatment groups
Group I Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Group II Patients receive 17-AAG IV over 1 hour on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 solid tumor 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
Once the MTD is determined 10 patients with either lymphoma or superficial solid tumors accessible for biopsy are treated as in group II at the MTD
Patients are followed for 3 months
PROJECTED ACCRUAL A total of 58-130 patients 30-72 for group I and 28-58 for group II will be accrued for this study within 2 years
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 |
|---|---|---|---|
| U01CA069912 | NIH | None | None |
| P30CA015083 | NIH | None | None |
| 990102 | OTHER | Mayo Clinic Cancer Center | httpsreporternihgovquickSearchP30CA015083 |