Status:
COMPLETED
Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
18-78 years
Phase:
PHASE2
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 pa...
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. Pat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00295984
Start Date
March 1 2006
End Date
August 1 2006
Last Update
June 20 2013
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182