Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
Ключавыя словы
Рэферат
Апісанне
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.
Даты
| Апошняя праверка: | 07/31/2006 |
| Упершыню прадстаўлена: | 02/22/2006 |
| Меркаваная колькасць заявак прадстаўлена: | 02/22/2006 |
| Першае паведамленне: | 02/23/2006 |
| Апошняе абнаўленне адпраўлена: | 06/17/2013 |
| Апошняе абнаўленне апублікавана: | 06/19/2013 |
| Фактычная дата пачатку даследавання: | 02/28/2006 |
| Разліковая дата завяршэння даследавання: | 07/31/2006 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Drug: nicotine
Фаза
Крытэрыі прыдатнасці
| Узрост, які мае права на вучобу | 18 Years Каб 18 Years |
| Пол, прыдатны для навучання | All |
| Прымае здаровых валанцёраў | Так |
| Крытэрыі | 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 |
Вынік
Першасныя вынікі
1. Tumor response at weeks 9 and 15 [undefined]
