Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00295984
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: nicotine	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial
• Study Start Date: Mar 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

1. Tumor response at weeks 9 and 15 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00295984
• Other Study ID Numbers: CDR0000462444; NCI-06-C-N033; NCT00339755
• First Posted: Feb 24, 2006
• Last Update Posted: Jun 20, 2013
• Last Verified: Aug 1, 2006

• Keywords provided by , ,: classic Kaposi sarcoma; recurrent Kaposi sarcoma
• Additional relevant MeSH terms: Sarcoma, Kaposi; Sarcoma; Nicotine

Study Results

No Results Posted as of Jun 20, 2013