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SarcomaPhase 2NCT00295984

Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

A Phase 2 study testing nicotine in people with Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 78 years
Conditions the study is for
Sarcoma
What is being tested?
nicotine
How many people
24 participants
Where
1 siteUnited States
Study dates
Mar 2006to Aug 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 78 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

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

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.

Read the 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
Being tested
nicotine
Keywords
classic Kaposi sarcoma, recurrent Kaposi sarcoma
Medical subject headings
Sarcoma, Sarcoma, Kaposi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nicotineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response at weeks 9 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2006 (estimated)
  2. Study startMar 2006
  3. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
Double blind
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295984
Sponsor's protocol ID
CDR0000462444
Other IDs
NCI-06-C-N033
Status last verified
Aug 2006
First submitted
23 Feb 2006
Last updated
20 Jun 2013
Results posted
No

Publications

  • 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.

    PubMed 18384551

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nicotine in people with Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response at weeks 9 and 15. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00295984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.

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