Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

imiquimod

conventional surgery

About this trial

This is an interventional treatment trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NIH - Warren Grant Magnuson Clinical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00079300

First Posted

March 8, 2004

Last Updated

April 25, 2013

Sponsor

National Naval Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00079300

Brief Title

Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Naval Medical Center

4. Oversight

5. Study Description

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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

imiquimod

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francesco M. Marincola, MD

Organizational Affiliation

NIH - Warren Grant Magnuson Clinical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

NIH - Warren Grant Magnuson Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892-1182

Country

United States

Non-melanomatous Skin Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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