Clinical trial NCT00295984: Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
Official title: Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Keywords: classic Kaposi sarcoma
recurrent Kaposi sarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor response at weeks 9 and 15
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: James J. Goedert, MD
role: STUDY_CHAIR
References:
citation: 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.