Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: nicotine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00295984

CDR0000462444

NCI-06-C-N033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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