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Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent.
Tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period.
The activity of the Hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the Ki67 index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole | Experimental | Oral Itraconazole capsules, 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole 200 mg | Drug | Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical response | tumor area response registered through dermatologic evaluation | 60 days |
| hedgehog pathway activity | Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment. | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renato M Bakos, Ph. D. | Contact | +555133598000 | 8619 | rbakos@hcpa.edu.br |
| Rodrigo P Pereira, M.D. | Contact | +555133598000 | 8619 | rppereira@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Renato M Bakos, Ph. D. | Hospital de Clinicas de Porto Alegre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035903 | Brazil |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D018295 |
| Neoplasms, Basal Cell |
| D010879 |
| Piperazines |