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Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00295984
First received: February 23, 2006
Last updated: February 24, 2009
Last verified: August 2006
History of Changes
  Purpose

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 Intervention Phase
Sarcoma
 Drug: nicotine
 Phase 2

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response at weeks 9 and 15 [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295984

Locations
United States, Maryland
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)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00295984     History of Changes
Obsolete Identifiers: NCT00339755
Other Study ID Numbers: CDR0000462444, NCI-06-C-N033
Study First Received: February 23, 2006
Last Updated: February 24, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
classic Kaposi sarcoma
recurrent Kaposi sarcoma

Additional relevant MeSH terms:
Sarcoma, Kaposi
Sarcoma
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013