Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day
18 Years
N/A
Both
Non-melanomatous Skin Cancer
Trial Information
Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
Francesco M. Marincola, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NIH - Warren Grant Magnuson Clinical Center
Authority:
United States: Federal Government
Study ID:
CDR0000355151
NCT ID:
NCT00079300
Start Date:
January 2004
Completion Date:
August 2005
Related Keywords:
- Non-melanomatous Skin Cancer
- basal cell carcinoma of the skin
- Skin Neoplasms
- Carcinoma, Basal Cell
Name | Location |
|---|---|
| NIH - Warren Grant Magnuson Clinical Center | Bethesda, Maryland 20892-1182 |
