Non-melanomatous Skin CancerPhase 1NCT00079300
Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
A Phase 1 study testing imiquimod and conventional surgery in people with Non-melanomatous Skin Cancer, run by National Naval Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanomatous Skin Cancer
- What is being tested?
- imiquimod and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Aug 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
NIH - Warren Grant Magnuson Clinical Center
Bethesda, Maryland, 20892-1182
About this study
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
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.
Read the 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.
- Conditions
- Non-melanomatous Skin Cancer
- Being tested
- imiquimod, conventional surgery
- Keywords
- basal cell carcinoma of the skin
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imiquimodDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2004 (estimated)
- Study startJan 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanomatous Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Naval Medical Center
- Sponsor type
- US federal agency
- Investigators
- Francesco M. Marincola, MD, Principal investigator, NIH - Warren Grant Magnuson Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079300
- Sponsor's protocol ID
- CDR0000355151
- Other IDs
- NCI-02-CC-0289, 3M-1454-IMIQ
- Status last verified
- Apr 2013
- First submitted
- 8 Mar 2004
- Last updated
- 26 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00079300
- Acronym / sponsor ID
- CDR0000355151
- Conditions
- Non-melanomatous Skin Cancer
- Keywords
- basal cell carcinoma of the skin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Naval Medical CenterUS federal agency
- Study start
- Jan 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 10 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imiquimod | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco M. Marincola, MD principal investigator
NIH - Warren Grant Magnuson Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing imiquimod and conventional surgery in people with Non-melanomatous Skin Cancer, run by National Naval Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.