Status:
COMPLETED
Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
Lead Sponsor:
National Naval Medical Center
Conditions:
Non-melanomatous Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 h...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00079300
Start Date
January 1 2004
End Date
August 1 2005
Last Update
April 26 2013
Active Locations (1)
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1
NIH - Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892-1182