Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024245
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-09-13
Brief Title:
10-Propargyl-10-Deazaaminopterin Plus Probenecid in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I and Clinical Pharamcologic Study of 10-Propargyl-10-Deazaaminopterin PDX in Combination With Probenecid in Adults With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2003-03
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 Probenecid may increase the effectiveness of 10-propargyl-10-deazaaminopterin by making tumor cells more sensitive to the drug
PURPOSE Phase I trial to study the effectiveness of combining 10-propargyl-10-deazaaminopterin and probenecid in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining 10-propargyl-10-deazaaminopterin and probenecid in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of 10-propargyl-10-deazaaminopterin and probenecid in patients with advanced solid tumors
Determine the therapeutic activity of this regimen in these patients
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of 10-propargyl-10-deazaaminopterin PDX and probenecid
Patients receive probenecid IV and PDX IV on day 1 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive sequentially escalating doses of probenecid and PDX until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 35-40 patients will be accrued for this study
Determine the maximum tolerated dose of 10-propargyl-10-deazaaminopterin and probenecid in patients with advanced solid tumors
Determine the therapeutic activity of this regimen in these patients
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of 10-propargyl-10-deazaaminopterin PDX and probenecid
Patients receive probenecid IV and PDX IV on day 1 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive sequentially escalating doses of probenecid and PDX until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 35-40 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 |
|---|---|---|---|
| NCI-H01-0077 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068905 | REGISTRY | None | None |