Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295984
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2006-02-23
Brief Title:
Nicotine Skin Patch in Treating Patients With Kaposis Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch A Phase II Trial
Status:
COMPLETED
Status Verified Date:
2006-08
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 Nicotine may stimulate the immune system to kill Kaposis sarcoma cells
PURPOSE This phase II trial is studying the side effects and how well the nicotine skin patch works in treating patients with Kaposis sarcoma
PURPOSE This phase II trial is studying the side effects and how well the nicotine skin patch works in treating patients with Kaposis sarcoma
Detailed Description:
OBJECTIVES
Evaluate the toxicity and efficacy of transdermal nicotine applied to lesions in patients with classic Kaposis Sarcoma
OUTLINE This is a double-blind placebo-controlled study
Patients apply a nicotine dermal patch to a selected lesion and a placebo patch to the other lesion replacing the same type of fresh patch every other day during the first 2 weeks increasing the nicotine dose in week 3 and again in week 5 for a total of 15 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Evaluate the toxicity and efficacy of transdermal nicotine applied to lesions in patients with classic Kaposis Sarcoma
OUTLINE This is a double-blind placebo-controlled study
Patients apply a nicotine dermal patch to a selected lesion and a placebo patch to the other lesion replacing the same type of fresh patch every other day during the first 2 weeks increasing the nicotine dose in week 3 and again in week 5 for a total of 15 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-06-C-N033 | None | None | None |