Sarcoma
Conditions
Keywords
classic Kaposi sarcoma, recurrent Kaposi sarcoma
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.
Interventions
DRUGnicotine
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response at weeks 9 and 15 | — |
Countries
United States
Outcome results
None listed