Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093405
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2004-10-06
Brief Title:
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin 17-AAGIn Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2005-11
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 such as 17-N-allylamino-17-demethoxygeldanamycin work in different ways to stop tumor cells from dividing so they stop growing or die 17-N-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic kidney cancer
PURPOSE This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in patients with metastatic papillary or clear cell renal cell carcinoma
Secondary
Determine the safety of this drug in these patients
Correlate tumor c-met expression with response in patients treated with this drug
OUTLINE This is an open-label study Patients are stratified according to histology papillary vs clear cell
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 60-90 minutes on days 1 4 8 and 11 Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 24-74 patients 12-37 per stratum will be accrued for this study within 6-20 months clear cell stratum and 2-5 years papillary stratum
Primary
Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in patients with metastatic papillary or clear cell renal cell carcinoma
Secondary
Determine the safety of this drug in these patients
Correlate tumor c-met expression with response in patients treated with this drug
OUTLINE This is an open-label study Patients are stratified according to histology papillary vs clear cell
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 60-90 minutes on days 1 4 8 and 11 Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 24-74 patients 12-37 per stratum will be accrued for this study within 6-20 months clear cell stratum and 2-5 years papillary stratum
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-04082 | None | None | None |
| NCI-6479 | None | None | None |