Overview

Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Nicotine
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