Clinical trial · Interventional
Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial
NCT00295984CI-TRIAL-00010877completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nicotine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor response at weeks 9 and 15
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGoedert 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. PMID 18384551