Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: nicotine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven classic Kaposi's sarcoma (KS) At least 2 KS lesions that can be measured (minimum diameter 0.5 cm to maximum diameter 3 cm) and located on body sites (leg, arm, torso, dorsum of foot or hand) to which a patch can be applied A third measurable lesion (if available) of the same size can be located on any body site KS lesions must be separated by at least 8.0 cm at their centers and 6.0 cm at closest edges Patient must be a nonsmoker No smoking, chewing, or other use of tobacco within the past year PATIENT CHARACTERISTICS: HIV antibody negative Willing to shower or bathe no more than every other day No life-threatening conditions Not pregnant Fertile patients must use effective contraception Chronic conditions (e.g., hypertension or diabetes) must be stable and well controlled No history of HIV/AIDS, unstable angina pectoris, or claudication ECOG performance status 0-1 PRIOR CONCURRENT THERAPY: No prior biopsy of the selected KS lesion(s) within the past 90 days No prior systemic therapy for KS within the past 90 days No concurrent systemic or local conventional treatment for KS No prior use of a nicotine product within the past year No prior surgery, chemotherapy, biologic therapy, or radiotherapy within the past 90 days No prior organ allograft

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nicotine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response at weeks 9 and 15 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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classic Kaposi sarcoma, recurrent Kaposi sarcoma