Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009971
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2001-02-02
Brief Title:
Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial Of Fenretinide NSC-374551 IND-40 294 In Patients With Relapsed Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2003-10
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:
Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the efficacy of fenretinide in terms of complete and partial response rates duration of response and survival in patients with recurrent small cell lung cancer
II Determine the toxicity of this regimen in these patients III Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates response duration and survival in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive oral fenretinide twice daily on days 1-7 Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month
I Determine the efficacy of fenretinide in terms of complete and partial response rates duration of response and survival in patients with recurrent small cell lung cancer
II Determine the toxicity of this regimen in these patients III Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates response duration and survival in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive oral fenretinide twice daily on days 1-7 Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month
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-T99-0112 | None | None | None |
| CCUM-9940 | None | None | None |