Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004213
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2000-01-28
Brief Title:
3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Dose Escalation Study to Evaluate Safety Tolerability and Pharmacokinetics of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone 3-AP in Cancer Patients Using a Single Daily Dose for Five Days
Status:
COMPLETED
Status Verified Date:
2007-12
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 Phase I trial to study the effectiveness of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone in treating patients who have solid tumors that have not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone in treating patients who have solid tumors that have not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the effects of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone 3-AP in patients with solid tumors by evaluating the safety and tolerability maximum tolerated dose MTD and recommended dose for Phase II studies pharmacokinetics and tumor response
OUTLINE This is a dose escalation study Patients receive 3-aminopyridine-2-carboxaldehyde thiosemicarbazone 3-AP IV over 2 hours on days 1-5 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 1-6 patients receive escalating doses of 3-AP 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 for 4 weeks or until recovered
PROJECTED ACCRUAL Approximately 21 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive 3-aminopyridine-2-carboxaldehyde thiosemicarbazone 3-AP IV over 2 hours on days 1-5 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 1-6 patients receive escalating doses of 3-AP 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 for 4 weeks or until recovered
PROJECTED ACCRUAL Approximately 21 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 |
|---|---|---|---|
| NCI-V99-1579 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067390 | REGISTRY | None | None |