Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282022
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2006-01-24
Brief Title:
VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Cloretazine VNP40101M for Patients With Relapsed or Refractory Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2009-01
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 tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well VNP40101M works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer
PURPOSE This phase II trial is studying how well VNP40101M works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the overall response rate partial and complete in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with VNP40101M
Determine the toxic effects of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease state sensitive relapse progressive disease 3 months after responding to first-line chemotherapy vs resistant disease progressive disease during or 3 months after first-line chemotherapy
Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks Treatment repeats every 6 weeks for up to 6 courses Patients achieving a complete response CR receive 2 additional courses of therapy after CR
After completion of study treatment patients are followed periodically for up to 18 months
PROJECTED ACCRUAL A total of 87 patients will be accrued for this study
Determine the overall response rate partial and complete in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with VNP40101M
Determine the toxic effects of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease state sensitive relapse progressive disease 3 months after responding to first-line chemotherapy vs resistant disease progressive disease during or 3 months after first-line chemotherapy
Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks Treatment repeats every 6 weeks for up to 6 courses Patients achieving a complete response CR receive 2 additional courses of therapy after CR
After completion of study treatment patients are followed periodically for up to 18 months
PROJECTED ACCRUAL A total of 87 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 |
|---|---|---|---|
| VION-CLI-039 | None | None | None |