Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	Pharmaceutical / Industry	NCI-02-CC-0289 3M-1454-IMIQ, NCT00079300

Objectives

Primary

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

Secondary

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

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

National Naval Medical Center

Francesco Marincola, MD, Principal investigator		Ph: 301-496-6357; 800-411-1222

Registry Information
Official 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
Trial Start Date		2004-01-30
Registered in ClinicalTrials.gov		NCT00079300
Date Submitted to PDQ		2004-01-30
Information Last Verified		2005-09-06

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