Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002586
Status:
COMPLETED
Last Update Posted:
2020-05-15
First Post:
1999-11-01
Brief Title:
13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
Status:
COMPLETED
Status Verified Date:
2020-05
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:
13-Cis
Brief Summary:
RATIONALE 13 Cis retinoic acid may prevent the development of cancer cells
PURPOSE Randomized double-blinded phase II trial to study the effectiveness of 13-cis retinoic acid with or without vitamin E for chemoprevention or observation of cancer in persons at high risk of developing lung cancer
PURPOSE Randomized double-blinded phase II trial to study the effectiveness of 13-cis retinoic acid with or without vitamin E for chemoprevention or observation of cancer in persons at high risk of developing lung cancer
Detailed Description:
OBJECTIVES
To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic acid administered for one year
To access the adequacy of the collected specimens for studies of intermediate endpoint markers
to establish a depository of biologic specimens for future studies of new biomarkers
Arm 1 Patients receive oral 13-cis retinoic acid daily
Arm 2 Patients receive oral 13-cis retinoic acid and oral vitamin E daily
Arm 3 Patients undergo observation only Treatment continues in arms I and II for 1 year in the absence of unacceptable toxicity
Patients are followed annually for 2 years
PROJECTED ACCRUAL A total of 100 patients 33 Arm 1 33 Arm 2 and 34 Arm 3 will be accrued for this study within 3 years
To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic acid administered for one year
To access the adequacy of the collected specimens for studies of intermediate endpoint markers
to establish a depository of biologic specimens for future studies of new biomarkers
Arm 1 Patients receive oral 13-cis retinoic acid daily
Arm 2 Patients receive oral 13-cis retinoic acid and oral vitamin E daily
Arm 3 Patients undergo observation only Treatment continues in arms I and II for 1 year in the absence of unacceptable toxicity
Patients are followed annually for 2 years
PROJECTED ACCRUAL A total of 100 patients 33 Arm 1 33 Arm 2 and 34 Arm 3 will be accrued for this study within 3 years
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-V94-0506 | OTHER_GRANT | National Cancer Institute | None |