Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

NCT00295984 | Completed Phase 2

• 2 other identifiers: CDR0000462444NCI-06-C-N033
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

classic Kaposi sarcoma; recurrent Kaposi sarcoma

Outcome Measures

Primary Outcomes (1)

• Tumor response at weeks 9 and 15

Interventions

nicotine DRUG

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related 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 Acad Dermatol Venereol. 2008 Sep;22(9):1101-9. doi: 10.1111/j.1468-3083.2008.02720.x. Epub 2008 Apr 1.

  PMID: 18384551 RESULT

MeSH Terms

Conditions

Sarcoma; Sarcoma, Kaposi

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• James J. Goedert, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 24, 2006
• Study Start: March 1, 2006
• Study Completion: August 1, 2006
• Last Updated: June 20, 2013

Record last verified: 2006-08

Locations

US (1)