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Status:

COMPLETED

Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Sarcoma

Eligibility:

All Genders

18-78 years

Phase:

PHASE2

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 pa...

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. Pat...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2006

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00295984

    Start Date

    March 1 2006

    End Date

    August 1 2006

    Last Update

    June 20 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, United States, 20892-1182