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


Phase 2
18 Years
78 Years
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Tumor response at weeks 9 and 15

Safety Issue:

No

Principal Investigator

James J. Goedert, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000462444

NCT ID:

NCT00295984

Start Date:

March 2006

Completion Date:

August 2006

Related Keywords:

  • Sarcoma
  • classic Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182