Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

NCT00079300 | Completed Phase 1

• 3 other identifiers: CDR0000355151NCI-02-CC-02893M-1454-IMIQ
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 how well imiquimod cream works in treating patients with basal cell skin cancer.

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin

Interventions

imiquimod DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Naval Medical Center: lead

Study Sites (1)

NIH - Warren Grant Magnuson Clinical Center

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Francesco M. Marincola, MD

  NIH - Warren Grant Magnuson Clinical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: January 1, 2004
• Study Completion: August 1, 2005
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

US (1)