Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

NCT ID: NCT00295984

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-08-31

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.

Conditions

Sarcoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

nicotine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

James J. Goedert, MD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18384551 (View on PubMed)

Other Identifiers

NCI-06-C-N033

Identifier Type: -

Identifier Source: secondary_id

CDR0000462444

Identifier Type: -

Identifier Source: org_study_id

NCT00339755

Identifier Type: -

Identifier Source: nct_alias