Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304005
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2006-03-15
Brief Title:
VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Cloretazine in Patients With RefractoryRelapsed Chronic Lymphocytic Leukemia or Richters Syndrome
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 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing
PURPOSE This phase III trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders
PURPOSE This phase III trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease phase I
Determine the toxic effects of this drug in these patients phase I
Determine the efficacy as determined by overall response rate of this drug at the MTD determined in phase I in these patients phase II
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Phase I Patients receive VNP40101M IV over 30 minutes on day 1 Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of VNP40101M 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 At least 6 patients are treated at the MTD
Phase II Patients receive VNP40101M at the MTD determined in phase I
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Determine the maximum tolerated dose MTD of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease phase I
Determine the toxic effects of this drug in these patients phase I
Determine the efficacy as determined by overall response rate of this drug at the MTD determined in phase I in these patients phase II
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Phase I Patients receive VNP40101M IV over 30 minutes on day 1 Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of VNP40101M 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 At least 6 patients are treated at the MTD
Phase II Patients receive VNP40101M at the MTD determined in phase I
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| MDA-2005-0249 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000465217 | REGISTRY | None | None |