Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
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.
|Study Design:||Masking: Double-Blind
Primary Purpose: Treatment
|Official Title:||Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial|
- Tumor response at weeks 9 and 15 [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||August 2006|
- 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.
|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)|