Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing.

PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Naval Medical Center
• Treatments: Imiquimod

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