Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059917
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-05-06
Brief Title:
Polyglutamate Camptothecin in Treating Patients With Advanced Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of CT-2106 in Patients With Advanced Malignancy
Status:
COMPLETED
Status Verified Date:
2005-04
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 polyglutamate camptothecin may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged
PURPOSE Phase I trial to study the effectiveness of polyglutamate camptothecin in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of polyglutamate camptothecin in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of polyglutamate camptothecin CT-2106 in patients with advanced malignancies
Determine the tolerability of this drug in these patients
Determine the safety of this drug in these patients
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Determine the disease response in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive polyglutamate camptothecin CT-2106 IV over 10 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients receive 2 additional courses beyond confirmation of complete response
Cohorts of 3-6 patients receive escalating doses of CT-2106 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
Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 12-48 patients will be accrued for this study
Determine the maximum tolerated dose of polyglutamate camptothecin CT-2106 in patients with advanced malignancies
Determine the tolerability of this drug in these patients
Determine the safety of this drug in these patients
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Determine the disease response in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study
Patients receive polyglutamate camptothecin CT-2106 IV over 10 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients receive 2 additional courses beyond confirmation of complete response
Cohorts of 3-6 patients receive escalating doses of CT-2106 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
Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 12-48 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000298987 | REGISTRY | PDQ Physician Data Query | None |
| MSKCC-03002 | None | None | None |