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Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nicotine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring classic Kaposi sarcoma, recurrent Kaposi sarcoma

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Tumor response at weeks 9 and 15

Secondary Outcome Measures

Full Information

First Posted
February 23, 2006
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00295984
Brief Title
Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
Official Title
Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
classic Kaposi sarcoma, recurrent Kaposi sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nicotine
Primary Outcome Measure Information:
Title
Tumor response at weeks 9 and 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J. Goedert, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18384551
Citation
Goedert JJ, Scoppio BM, Pfeiffer R, Neve L, Federici AB, Long LR, Dolan BM, Brambati M, Bellinvia M, Lauria C, Preiss L, Boneschi V, Whitby D, Brambilla L. Treatment of classic Kaposi sarcoma with a nicotine dermal patch: a phase II clinical trial. J Eur Acad Dermatol Venereol. 2008 Sep;22(9):1101-9. doi: 10.1111/j.1468-3083.2008.02720.x. Epub 2008 Apr 1.
Results Reference
result

Learn more about this trial

Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

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