Know Cancer

or
forgot password

Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer

Thank you

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 CenterBethesda, Maryland  20892-1182