Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

June 18, 2013 updated by: National Cancer Institute (NCI)

Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Tumor response at weeks 9 and 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: James J. Goedert, MD, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000462444
  • NCI-06-C-N033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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