Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
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|ClinicalTrials.gov Identifier: NCT00295984|
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : June 20, 2013
RATIONALE: Nicotine may stimulate the immune system to kill Kaposi's sarcoma cells.
PURPOSE: This phase II trial is studying the side effects and how well the nicotine skin patch works in treating patients with Kaposi's sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: nicotine||Phase 2|
- Evaluate the toxicity and efficacy of transdermal nicotine applied to lesions in patients with classic Kaposi's 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Official Title:||Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial|
|Study Start Date :||March 2006|
|Actual Study Completion Date :||August 2006|
- Tumor response at weeks 9 and 15
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295984
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||James J. Goedert, MD||National Cancer Institute (NCI)|