Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295984
• Other study ID #: CDR0000462444
• Secondary ID: NCI-06-C-N033
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2006
• Last updated: June 18, 2013
• Start date: March 2006
• Est. completion date: August 2006

Study information

• Verified date: August 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00339755

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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 Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• nicotine

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response at weeks 9 and 15			No