Overview

Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer. PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Queen's Medical Centre
Treatments:
Imiquimod
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed primary basal cell skin carcinoma

- Nodular or superficial lesion(s)*

- Located in low-risk areas NOTE: *Any number of lesions are allowed but only 1
lesion per patient is selected for the study

- No genetic or nevoid conditions (e.g., Gorlin's syndrome)

- No morphoeic (microinfiltrative) histology

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- No bleeding disorder

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 1 month after
study participation

- No allergy to any of the study interventions

- No life-threatening disease

- Must be available for study follow-up for up to 3 years

- Must have access to a telephone

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No concurrent participation in any other experimental trial