Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006383
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2000-10-04
Brief Title:
Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkins Lymphoma
Sponsor:
Inex Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkins Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 0301 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkins Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy
Status:
COMPLETED
Status Verified Date:
2002-12
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the complete and partial tumor responses in patients with aggressive non-Hodgkins lymphoma that is refractory to or relapsed after second-line combination chemotherapy treated with vincristine sulfate liposomes injection
Determine the toxicity of this treatment regimen in these patients
Determine the duration of response time to progression and survival in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive vincristine sulfate liposomes IV over 1 hour Treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 1 year
Determine the complete and partial tumor responses in patients with aggressive non-Hodgkins lymphoma that is refractory to or relapsed after second-line combination chemotherapy treated with vincristine sulfate liposomes injection
Determine the toxicity of this treatment regimen in these patients
Determine the duration of response time to progression and survival in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive vincristine sulfate liposomes IV over 1 hour Treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| UCLA-0002028 | None | None | None |
| INEX-CA99002 | None | None | None |