Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Phase 2

Completed

• Conditions: Sarcoma

• Registration Number: NCT00295984
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-24
• Study Start: 2006-03
• Status Verified: 2006-08
• Study Completion: 2006-08
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor response at weeks 9 and 15

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States