Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006218
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2000-09-11
Brief Title:
3-AP in Treating Patients With Advanced Cancer
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone 3-AP Triapine in Cancer Patients Using a 96-Hour Intravenous Continuous Infusion
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-AP in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of 3-AP in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine the safety tolerability and toxicity of 3-AP in patients with advanced malignancies II Determine the maximum tolerated dose and recommended phase II dose of this treatment in these patients III Determine the pharmacokinetic parameters of this treatment in these patients IV Determine the tumor response in these patients treated with this regimen
OUTLINE This is a dose escalation multicenter study Patients receive 3-AP IV continuously over 96 hours Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with complete response receive treatment for 1 course past the course in which the complete response was documented patients with partial response may receive treatment for up to 1 year and patients with stable disease may receive treatment for up to 6 months During the accelerated phase of the study cohorts of 1 patient each receive escalating doses of 3-AP until one patient experiences dose limiting toxicity DLT or 2 different patients experience grade 2 toxicity during any course When the accelerated phase ends cohorts of 3-6 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 DLT
PROJECTED ACCRUAL Approximately 21 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study Patients receive 3-AP IV continuously over 96 hours Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with complete response receive treatment for 1 course past the course in which the complete response was documented patients with partial response may receive treatment for up to 1 year and patients with stable disease may receive treatment for up to 6 months During the accelerated phase of the study cohorts of 1 patient each receive escalating doses of 3-AP until one patient experiences dose limiting toxicity DLT or 2 different patients experience grade 2 toxicity during any course When the accelerated phase ends cohorts of 3-6 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 DLT
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-V00-1598 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068067 | REGISTRY | None | None |
| AECM-12000041110 | None | None | None |