Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020202
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-02
Brief Title:
FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of FR901228 in Patients With Refractory or Progressive Small Cell or Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of FR901228 in treating patients who have refractory or progressive small cell lung cancer or non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of FR901228 in treating patients who have refractory or progressive small cell lung cancer or non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the response of patients with refractory or progressive small cell or non-small cell lung cancer to FR901228
II Determine the ability of FR901228 to mediate apoptosis and target gene induction relative to tumor histology in these patients
III Determine the toxicity of this treatment in these patients
PROTOCOL OUTLINE Patients are stratified according to disease histology small cell lung cancer vs non-small cell lung cancer
Patients receive FR901228 IV over 4 hours on days 1 and 7 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL
A total of 18-43 patients 9-21 per arm will be accrued for this study within 18 months
II Determine the ability of FR901228 to mediate apoptosis and target gene induction relative to tumor histology in these patients
III Determine the toxicity of this treatment in these patients
PROTOCOL OUTLINE Patients are stratified according to disease histology small cell lung cancer vs non-small cell lung cancer
Patients receive FR901228 IV over 4 hours on days 1 and 7 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL
A total of 18-43 patients 9-21 per arm will be accrued for this study within 18 months
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-1053 | None | None | None |
| NCI-00-C-0123 | None | None | None |