Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2013
• Main ID: NCT00079300
• Date of registration: 08/03/2004
• Primary sponsor: National Naval Medical Center
• Public title: Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
• Scientific title: Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day
• Date of first enrolment: January 2004
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00079300
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Francesco M. Marincola, MD
• Affiliation: NIH - Warren Grant Magnuson Clinical Center

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed basal cell skin cancer

- Superficial or nodular disease

- No aggressive disease

- At least 1 lesion at least 7 mm in diameter that meets the following criteria:

- Primary tumor (no recurrent or previously treated disease)

- Located on the scalp, face (including ears), trunk, or proximal extremities

- Qualifies for surgical excision as primary therapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No evidence of a clinically significant or unstable medical condition that would
adversely affect blood circulation

Other

- No dermatological disease (e.g., psoriasis or eczema) at the treatment site that may
be exacerbated by treatment with imiquimod or interfere with examination

- No febrile viral infection within the past 4 weeks

- No evidence of a clinically significant or unstable medical condition that would
adversely affect immune function

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior interferon, interferon inducers, or immunomodulators

- No concurrent interferon, interferon inducers, or immunomodulators

Chemotherapy

- More than 6 months since prior anticancer chemotherapy

- No concurrent anticancer chemotherapy

Endocrine therapy

- More than 4 weeks since prior oral or inhaled (more than 600 mcg/day for fluticasone
or equivalent) corticosteroids

- More than 4 weeks since prior topical steroids to the target tumor

- Concurrent topical steroids in non-target areas are allowed provided amount used is =
2 g of fluorinated steroids daily for > 1 week or 6 g of beclomethasone for > 1 week

- No concurrent oral or inhaled corticosteroids

Radiotherapy

- Not specified

Surgery

- More than 4 months since prior biopsy

Other

- More than 4 weeks since prior immunosuppressive therapies

- More than 4 weeks since prior cytotoxic or investigational drugs

- No concurrent immunosuppressive therapies

- No other concurrent cytotoxic or investigational drugs



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-melanomatous Skin Cancer

Intervention(s)

Drug: imiquimod

Procedure: conventional surgery

Secondary ID(s)

3M-1454-IMIQ

CDR0000355151

NCI-02-CC-0289

Source(s) of Monetary Support

Please refer to primary and secondary sponsors