| ID | Type | Description | Link |
|---|---|---|---|
| NCI-06-C-N033 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response at weeks 9 and 15 |
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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
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| James J. Goedert, MD | National Cancer Institute (NCI) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18384551 | Result | Goedert JJ, Scoppio BM, Pfeiffer R, Neve L, Federici AB, Long LR, Dolan BM, Brambati M, Bellinvia M, Lauria C, Preiss L, Boneschi V, Whitby D, Brambilla L. Treatment of classic Kaposi sarcoma with a nicotine dermal patch: a phase II clinical trial. J Eur Acad Dermatol Venereol. 2008 Sep;22(9):1101-9. doi: 10.1111/j.1468-3083.2008.02720.x. Epub 2008 Apr 1. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D012514 | Sarcoma, Kaposi |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006566 | Herpesviridae Infections |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009383 | Neoplasms, Vascular Tissue |
| D006573 |
| Heterocyclic Compounds, 1-Ring |