Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day

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.

OBJECTIVES:

Primary

• Compare levels of apoptosis in patients with basal cell skin cancer treated with vs without imiquimod 5% cream.

Secondary

• Compare levels of apoptosis in patients treated with this drug on two different administration schedules.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study.

Patients undergo fine needle aspiration and punch biopsies of the target lesion. Patients are then randomized to 1 of 8 treatment arms and begin therapy within 30 days after biopsy.

• Arm I: Patients apply topical imiquimod to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses.
• Arm II: Patients apply topical placebo to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses.
• Arm III: Patients apply topical imiquimod to the target lesion once every 24 hours on days 1-4 for a total of 4 doses.
• Arm IV: Patients apply topical placebo to the target lesion once every 24 hours on days 1-4 for a total of 4 doses.
• Arm V: Patients apply topical imiquimod to the target lesion once every 12 hours on days 1-4 for a total of 8 doses.
• Arm VI: Patients apply topical placebo to the target lesion once every 12 hours on days 1-4 for a total of 8 doses.
• Arm VII: Patients apply topical imiquimod to the target lesion once every 24 hours on days 1-8 for a total of 8 doses.
• Arm VIII: Patients apply topical placebo to the target lesion every 24 hours on days 1-8 for a total of 8 doses.

All patients undergo excision of the target tumor within 18-30 hours after the last topical treatment.

Patients are followed at 7-14 days.

PROJECTED ACCRUAL: A total of 48 patients (8 per treatment arm and 4 per placebo arm) will be accrued for this study.

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