Carcinoma, Basal CellPhase 4NCT00204555
Safety and Efficacy Study of Imiquimod 5% Cream Applied 3x Per Week for 8 or 12 Weeks in Low Risk Nodular Basal Cell Carcinoma
A Phase 4 study testing Imiquimod in people with Carcinoma, Basal Cell, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs. Three phase II dose response studies in subjects with nodular BCC (nBCC) showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- Imiquimod
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2002to Sep 2005
- Phase
- Phase 4
- 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
Who may be able to join
- Patients who are able to understand and willing to give informed consent prior to study procedures
- Age 18+
- Have one BCC which meets the following criteria: a primary tumor (not recurrent, not previously biopsied or treated; non-infected; located on the limbs, trunk (anogenital area excluded), neck, or head. The target tumor must be visible; maximum tumor area of 1.5 cm in diameter; macroscopically (clinically) consistent with nodular BCC; nodular subtype, with circumscribed growth pattern; histologically consistent with nBCC, and having no histological evidence of aggressive growth patterns; easily identifiable and treatable by subject or reliable subject representative;
- Are willing and able to participate in the study as an outpatient, making necessary visits to the clinic during the treatment period and comply with study requirements, including the following: A minimum of 1 and a maximum of 3 prestudy confirmatory biopsies of different tumors before beginning study drug treatment (each biopsy will remove no more than 25% of the target tumor); at least 4 or 5 clinic visits during the study; blood sampling at screening/initiation visit and end of treatment; urine pregnancy testing for females of childbearing potential at the screening/initiation visit and the end of treatment visits
- Are free of any significant physical abnormalities at the potential application site area, which would interfere with assessment of possible site reactions (eg, eczema, psoriasis, tattoos)
- If female and of childbearing potential, has negative urine pregnancy tests during screening/initiation visit, and is willing to use a medically acceptable method of contraception during the treatment period
Who cannot join
- High-risk areas within 0.5 cm of the eyes
- Have evidence of clinically significant, unstable medical conditions such as metastatic tumor or tumor with high probability of metastatic spread, cardiovascular (NYHA class III, IV), immunomodulation or immunosuppressive therapies, hematologic, hepatic, renal, neurologic, endocrine, collagen-vascular, gastrointestinal
- Have or had other malignant tumors of the skin within the target tumor site or surrounding area (eg, malignant melanoma, epithelioma spinocellular, squamous cell carcinoma). The surrounding area includes the skin within 2 cm of the target site margins in all directions
- Have received the following treatments for any indication in the target tumor site or surrounding area within the designated time period (6 weeks) before treatment initiation: Topical retinoids, Topical steroids, Surgical excision, Curettage, Cryo-, Thermo- or Chemodestruction, Photodynamic therapy, Therapeutic UV-Radiation
- Have received the following systemic treatments within the designated period before study treatment initiation: Interferon (6 weeks), Immunomodulators or immunosuppressive therapies (10 weeks), Cytotoxic drugs (6 months), Investigational drugs (8 weeks), Drugs known to have major organ toxicity (8 weeks), Corticosteroids (oral or injectable) (6 weeks), Inhaled corticosteroids (>1200 ng/day for beclomethasone, or >600 ng/day for fluticasone)(4 weeks)
- Have received any systemic cancer chemotherapy within 6 months before study treatment initiation
Show all 12Show fewer
- Have known allergies to any excipient in the study cream (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan monostearate, white petrolatum, glycerin, methyl paraben, propyl paraben, purified water, and xanthan gum
- Are known to be pregnant or lactating (currently or within the past 3 months). If the subject was pregnant, at least 3 months must have elapsed since parturition or termination
- Have any dermatological disease in the target tumor site or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (eg psoriasis, eczema)
- Are currently or within the past 8 weeks participating in another clinical study
- Have active chemical dependency or alcoholism as assessed by the investigator
- Have had a systemic bacterial or viral infection within 2 weeks prior to study initiation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: A Randomized Open Label Study to Evaluate the Safety and Efficacy if Imiquimod 5% Cream Applied 3 Times Per Week for 8 or 12 Weeks in the Treatment of Low Risk Nodular Basal Cell Carcinoma
Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs. Three phase II dose response studies in subjects with nodular BCC (nBCC) showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment. Daily dosing or 5 times per week applications showed higher total clearance rates than 3 times per week dosing or less frequent dosing. Furthermore, a 12 week treatment period resulted in better efficacy results than a duration of only 6 weeks. On the other hand, local skin reactions increased with the doses applied per week. So a prolonged treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be a good compromise between efficacy and safety.
Read the detailed description
Basal cell carcinoma (BCC) is a malignant skin cancer that is believed to develop from the basal layer of the epidermis. Ultraviolet (UV) radiation is the primary cause of BCC. It induces local and systemic immuno-suppression, p53 mutations, pyrimidine covalent dimers in desoxyribonucleic acid (DNA), and bcl-2 overexpression. All of these UV-induced changes are believed to be critical in the pathogenesis of BCC.
Topical application of imiquimod induces local interferon-alpha (IFN-alpha), interleukin-12 (IL-12), and tumor necrosis factor-alpha (TNF-alpha), with a resulting cytokine cascade that may induce and/or support a cytotoxic T-lymphocyte (Th1) immune response. Intralesional IFN-alpha has been shown to be effective for the treatment of BCC. Imiquimod may be an effective therapy for BCC.
Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs. Three phase II dose response studies in subjects with nodular BCC (nBCC) showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment. Daily dosing or 5 times per week applications showed higher total clearance rates than 3 times per week dosing or less frequent dosing. Furthermore, a 12 week treatment period resulted in better efficacy results than a duration of only 6 weeks. On the other hand, local skin reactions increased with the doses applied per week. So a prolonged treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be a good compromise between efficacy and safety.
The current safety and efficacy study of imiquimod 5% cream in the treatment of nodular basal cell carcinoma (nBCC) will use a composite endpoint including both a clinical (visual) assessment of the target tumor site and a histological evaluation of an excisional surgery taken from the target tumor site for primary assessment of complete tumor clearance 8 weeks post treatment.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- Imiquimod
- Keywords
- nodular basal cell carcinoma, Imiquimod, topical treatment, Adjuvants, Immunologic, Antineoplastic Agents, Interferon Inducers
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clearance rate, defined as the proportion of subjects who are clinically and histologically clear of BCC at the treated nodular BCC target tumor site at the 8 week post-treatment visit
Secondary outcomes (2)
intensity of local skin reactions such as erythema, vesicles, scarring
Measured: every 4 weeks during treatment
Cosmetic outcome
Measured: 8 weeks posttreamnt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Claus Garbe, MD, Principal investigator, Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204555
- Sponsor's protocol ID
- BCC-IMI-001
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 1 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Study to Evaluate the Safety and Efficacy if Imiquimod 5% Cream Applied 3 Times Per Week for 8 or 12 Weeks in the Treatment of Low Risk Nodular Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00204555
- Acronym / sponsor ID
- BCC-IMI-001
- Conditions
- Carcinoma, Basal Cell
- Keywords
- nodular basal cell carcinoma, Imiquimod, topical treatment, Adjuvants, Immunologic, Antineoplastic Agents, Interferon Inducers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Sep 2005 (actual)
- First posted
- 20 Sep 2005 (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.
Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs. Three phase II dose response studies in subjects with nodular BCC (nBCC) showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment. Daily dosing or 5 times per week applications showed higher total clearance rates than 3 times per week dosing or less frequent dosing. Furthermore, a 12 week treatment period resulted in better efficacy results than a duration of only 6 weeks. On the other hand, local skin reactions increased with the doses applied per week. So a prolonged treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be a good compromise between efficacy and safety.
Detailed description
Basal cell carcinoma (BCC) is a malignant skin cancer that is believed to develop from the basal layer of the epidermis. Ultraviolet (UV) radiation is the primary cause of BCC. It induces local and systemic immuno-suppression, p53 mutations, pyrimidine covalent dimers in desoxyribonucleic acid (DNA), and bcl-2 overexpression. All of these UV-induced changes are believed to be critical in the pathogenesis of BCC.
Topical application of imiquimod induces local interferon-alpha (IFN-alpha), interleukin-12 (IL-12), and tumor necrosis factor-alpha (TNF-alpha), with a resulting cytokine cascade that may induce and/or support a cytotoxic T-lymphocyte (Th1) immune response. Intralesional IFN-alpha has been shown to be effective for the treatment of BCC. Imiquimod may be an effective therapy for BCC.
Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs. Three phase II dose response studies in subjects with nodular BCC (nBCC) showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment. Daily dosing or 5 times per week applications showed higher total clearance rates than 3 times per week dosing or less frequent dosing. Furthermore, a 12 week treatment period resulted in better efficacy results than a duration of only 6 weeks. On the other hand, local skin reactions increased with the doses applied per week. So a prolonged treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be a good compromise between efficacy and safety.
The current safety and efficacy study of imiquimod 5% cream in the treatment of nodular basal cell carcinoma (nBCC) will use a composite endpoint including both a clinical (visual) assessment of the target tumor site and a histological evaluation of an excisional surgery taken from the target tumor site for primary assessment of complete tumor clearance 8 weeks post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are able to understand and willing to give informed consent prior to study procedures
- Age 18+
- Have one BCC which meets the following criteria: a primary tumor (not recurrent, not previously biopsied or treated; non-infected; located on the limbs, trunk (anogenital area excluded), neck, or head. The target tumor must be visible; maximum tumor area of 1.5 cm in diameter; macroscopically (clinically) consistent with nodular BCC; nodular subtype, with circumscribed growth pattern; histologically consistent with nBCC, and having no histological evidence of aggressive growth patterns; easily identifiable and treatable by subject or reliable subject representative;
- Are willing and able to participate in the study as an outpatient, making necessary visits to the clinic during the treatment period and comply with study requirements, including the following: A minimum of 1 and a maximum of 3 prestudy confirmatory biopsies of different tumors before beginning study drug treatment (each biopsy will remove no more than 25% of the target tumor); at least 4 or 5 clinic visits during the study; blood sampling at screening/initiation visit and end of treatment; urine pregnancy testing for females of childbearing potential at the screening/initiation visit and the end of treatment visits
- Are free of any significant physical abnormalities at the potential application site area, which would interfere with assessment of possible site reactions (eg, eczema, psoriasis, tattoos)
Key exclusion criteria (12 listed)
- High-risk areas within 0.5 cm of the eyes
- Have evidence of clinically significant, unstable medical conditions such as metastatic tumor or tumor with high probability of metastatic spread, cardiovascular (NYHA class III, IV), immunomodulation or immunosuppressive therapies, hematologic, hepatic, renal, neurologic, endocrine, collagen-vascular, gastrointestinal
- Have or had other malignant tumors of the skin within the target tumor site or surrounding area (eg, malignant melanoma, epithelioma spinocellular, squamous cell carcinoma). The surrounding area includes the skin within 2 cm of the target site margins in all directions
- Have received the following treatments for any indication in the target tumor site or surrounding area within the designated time period (6 weeks) before treatment initiation: Topical retinoids, Topical steroids, Surgical excision, Curettage, Cryo-, Thermo- or Chemodestruction, Photodynamic therapy, Therapeutic UV-Radiation
- Have received the following systemic treatments within the designated period before study treatment initiation: Interferon (6 weeks), Immunomodulators or immunosuppressive therapies (10 weeks), Cytotoxic drugs (6 months), Investigational drugs (8 weeks), Drugs known to have major organ toxicity (8 weeks), Corticosteroids (oral or injectable) (6 weeks), Inhaled corticosteroids (>1200 ng/day for beclomethasone, or >600 ng/day for fluticasone)(4 weeks)
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 | – |
Primary outcome
Evaluate the clearance rate, defined as the proportion of subjects who are clinically and histologically clear of BCC at the treated nodular BCC target tumor site at the 8 week post-treatment visit
2 secondary outcomes
intensity of local skin reactions such as erythema, vesicles, scarring
Time frame: every 4 weeks during treatment
Cosmetic outcome
Time frame: 8 weeks posttreamnt
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 1 Sep 2011.
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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.
Claus Garbe, MD principal investigator
Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imiquimod in people with Carcinoma, Basal Cell, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. 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 1 Sep 2011. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Evaluate the clearance rate, defined as the proportion of subjects who are clinically and histologically clear of BCC at the treated nodular BCC target tumor site at the 8 week post-treatment visit. It is what the study was designed to measure, not a finding.
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 1 Sep 2011.