Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083187
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2004-05-14
Brief Title:
VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of VNP40101M For Patients With Acute Myelogenous Leukemia Or High-Risk Myelodysplasia
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as VNP40101M and hydroxyurea work in different ways to stop cancer cells from dividing so they stop growing or die Hydroxyurea may help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug
PURPOSE This phase II trial is studying how well giving VNP40101M with hydroxyurea works in treating patients with acute myelogenous leukemia or high-risk myelodysplasia
PURPOSE This phase II trial is studying how well giving VNP40101M with hydroxyurea works in treating patients with acute myelogenous leukemia or high-risk myelodysplasia
Detailed Description:
OBJECTIVES
Determine the complete response rate to VNP40101M in patients with acute myelogenous leukemia or high-risk myelodysplasia
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is an open-label multicenter study Patients are stratified to acute myelogenous leukemia AML or high risk myelodysplasia MDS patients 60 years old with no prior treatment vs AML patients any age in first relapse AML patients any age in first relapse closed to accrual 060905
Patients receive VNP40101M IV over 30 minutes once on day 1 course 1
Four to five weeks after the first course patients undergo bone marrow aspiration and biopsy If the bone marrow is improved but contains residual leukemia patients receive a second course of VNP40101M at the same dose as in course 1 If patients achieve complete response CR or partial CR after the first or second course a consolidation course may be given comprising VNP40101M at a reduced dose
Patients are followed monthly for 6 months every 2 months for 12 months and then every 3 months for 18 months
PROJECTED ACCRUAL A total of 230 patients 100 with acute myelogenous leukemia AML or high-risk myelodysplasia and 130 with AML in first relapse will be accrued for this study
Determine the complete response rate to VNP40101M in patients with acute myelogenous leukemia or high-risk myelodysplasia
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is an open-label multicenter study Patients are stratified to acute myelogenous leukemia AML or high risk myelodysplasia MDS patients 60 years old with no prior treatment vs AML patients any age in first relapse AML patients any age in first relapse closed to accrual 060905
Patients receive VNP40101M IV over 30 minutes once on day 1 course 1
Four to five weeks after the first course patients undergo bone marrow aspiration and biopsy If the bone marrow is improved but contains residual leukemia patients receive a second course of VNP40101M at the same dose as in course 1 If patients achieve complete response CR or partial CR after the first or second course a consolidation course may be given comprising VNP40101M at a reduced dose
Patients are followed monthly for 6 months every 2 months for 12 months and then every 3 months for 18 months
PROJECTED ACCRUAL A total of 230 patients 100 with acute myelogenous leukemia AML or high-risk myelodysplasia and 130 with AML in first relapse 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 |
|---|---|---|---|
| CDR0000365510 | REGISTRY | PDQ Physician Data Query | None |