Protocol Number: 02-CC-0289

Title:

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

Number:

02-CC-0289

Summary:

This study will evaluate the effectiveness of Aldara™ (Trademark) (Imiquimod) Cream in treating basal cell carcinoma (skin cancer).

Patients 18 years of age and older with an untreated suspected basal cell carcinoma may be eligible for this study.

First Visit:

Participants will have a medical history taken. A blood sample will be drawn and a doctor will examine, measure, and photograph the skin lesion. Two punch skin biopsies (surgical removal of a small piece of tissue for microscopic examination), will be taken from the area of the skin cancer, each less than 1/8th inch in diameter. One sample will be examined to confirm the diagnosis of basal cell carcinoma; the other will be sent to a laboratory for special tests that will be compared with another skin sample taken after treatment. In addition, a small amount of tissue will be removed from the area of skin cancer with a very fine needle. Patients will be shown how to apply the study cream and will be given a dosing kit with a supply of cream to take home. The cream contains either Aldara cream or a placebo (look-alike cream with no active ingredient).

Treatment Initiation

Patients will be randomly assigned to one of four treatment dosing groups. They will apply the cream as instructed in their kit according to one of the following schedules:

- Four doses, one dose every 12 hours, twice a day

- Four doses, one dose every 24 hours, once a day

- Eight doses, one dose every 12 hours, twice a day

- Eight doses, one dose every 24 hours, once a day

End-of-Treatment Visit

Patients will come to the clinic about 24 hours after their last dose for an end-of-treatment visit. A doctor will examine and photograph the skin cancer area. A second punch biopsy and fine needle aspiration will be taken and sent for special tests at a research laboratory. The doctor will then surgically remove the entire skin cancer and send it to a laboratory to be examined for skin cancer cells.

Upon starting treatment and at each clinic visit, participants will report any illnesses, side effects, or reactions to the study drug and will be asked about any medications they have taken.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Subjects are eligible for the study if they meet all of the following criteria:

1. Willingness to give written informed consent prior to undergoing prestudy procedures specific to this study

2. Male or female

3. At least 18 years of age

4. Have at least one BCC lesion that meets the following criteria:

-Primary tumor (not recurrent or previously treated. The tumor may have been biopsied greater than 4 months prior to prestudy, but must not have been treated in any way.

-Qualifies, in the opinion of the investigator, for surgical excision as a primary therapy

-Located on the scalp, face (including ears), trunk, or proximal extremities

-Minimum diameter of 5 mm

-Histologically consistent with either superficial or nodular BCC (but not aggressive)

-Easily identifiable and treatable by the subject or reliable subject representative

EXCLUSION CRITERIA:

Subjects may not participate in this study if they have

1. Evidence of clinically significant or unstable medical condition(s) that would be expected to adversely affect either blood circulation or immune function

2. Had a febrile viral infection within 4 weeks of treatment initiation

3. Any dermatological disease at the treatment site that may be exacerbated by treatment with Imiquimod or cause difficulty with examination (eg, psoriasis, eczema)

4. Received any type of treatment to the target tumor

5. Received any cancer chemotherapy within 6 months before treatment initiation

6. Received any of the following treatment within 4 weeks before treatment initiation:

Interferon or interferon inducers

Immunomodulators or immunosuppressive therapies

Cytotoxic drugs

Investigational drugs

Oral corticosteriods

Inhaled corticosteriods (greater than 600 mcg/day for fluticasone or equivalent)

Topical steroids to the target tumor (Topical steroid use in locations other than the treatment area will be allowed during the study provided the amount used does not exceed 2-gm fluorinated steroids daily for greater than 1 week or 6 gm of beclomethasone for greater than 1 week.

Special Instructions:

Protocol is being conducted at NNMC and recruiting military personnel only.

Keywords:

Basal Cell Cancer

Aldara

Imiquimod

Immunotherapy

Antigen Presentation

Recruitment Keywords:

Basal Cell Carcinoma

BCC

Basal Cell Cancer

Conditions:

Basal Cell Carcinoma

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Wong DA, Bishop GA, Lowes MA, Cooke B, Barnetson RS, Halliday GM. Cytokine profiles in spontaneously regressing basal cell carcinomas. Br J Dermatol. 2000 Jul;143(1):91-8. PMID: 10886141

Gutierrez-Steil C, Wrone-Smith T, Sun X, Krueger JG, Coven T, Nickoloff BJ. Sunlight-induced basal cell carcinoma tumor cells and ultraviolet-B-irradiated psoriatic plaques express Fas ligand (CD95L). J Clin Invest. 1998 Jan 1;101(1):33-9. PMID: 9421463

Poppema S, Potters M, Visser L, van den Berg AM.

Immune escape mechanisms in Hodgkin's disease. Ann Oncol. 1998;9 Suppl 5:S21-4. Review. PMID: 9926233

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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