Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma (NICCI)
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|ClinicalTrials.gov Identifier: NCT03035188|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : October 17, 2019
In this study patients with resectable basal cell carcinoma (BCC) who usually undergo surgery without prior anticancer treatment will be treated with antitumor medication. But since BCC is mainly localized in clearly visible regions of the body, as e.g. the face, there is also a need to reduce scars as a consequence of surgery which will be accomplished by neoadjuvant therapy.
The used medication - vismodegib - displays controllable adverse events and shows a good efficacy for reduction of BCC lesions. It is expected that the neoadjuvant setting will lead to minor surgical intervention thus minimising surgical risks and scars for the patients.
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Drug: Vismodegib||Phase 2|
Patients with resectable BCC will receive neoadjuvant vismodegib therapy for a time period of 12 weeks which applies to the routine use of vismodegib. This period is chosen because within this time side effects are acceptable and response is expected. Tumor examination will be performed monthly to expeditiously identify patients with progressive disease. This will be done by non-invasive imaging techniques thus a further objective of this study is the testing of diagnostic suitability of non-invasive methodology for the evaluation of response status of the patients.
Patients in this clinical trial will be treated with an effective medication which is approved for the therapy of metastatic and locally advanced BCC for a time having been shown to be effective in neoadjuvant setting The same dose as approved for the advanced BCC disease is used, therefore it can be expected that the side effects will be predictable. Furthermore there are no hints in literature that the efficacy of the used medication may be decreased in patients with resectable BCC.
Since the study patients are less sick than those for whom treatment with vismodegib is approved, surgery would be their therapy according to guideline. Thus the risk of vismodegib treatment has to be judged against the greater surgical risk if BCC will be operated directly without prior reduction of tumor lesion. A benefit for the great majority of the patients will be that smaller lesions result in minor scars and better cosmetically outcome of surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single-armed, Multicenter Trial of Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Continuous once-daily oral dosing of vismodegib at a dosage of 150 mg per administration
1 capsule (150 mg vismodegib) taken once daily for a maximum of 12 weeks.
Other Name: Erivedge
- Disease control rate (DCR) defined as complete response (CR), partial response (PR), or stable disease (SD) after 12 weeks of treatment with vismodegib [ Time Frame: 12 weeks ]Rate of patients with CR, PR and SD
- Objective and relative (%) reduction of the involved skin surface after 12 weeks of treatment with vismodegib [ Time Frame: 12 weeks ]Percent change of the BCC area from baseline to end of study therapy
- DCR (CR, PR, or SD) after 12 weeks of treatment with vismodegib in the neoadjuvant treatment setting for different basal cell carcinoma histotypes (superficial, scleroderma, nodular, others) [ Time Frame: 12 weeks ]
- Duration of overall response (DoR) [ Time Frame: 12 months ]Time from documented CR, PR or SD until progression of disease
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]
- Health-related quality of life in patients receiving vismodegib for neoadjuvant treatment of basal cell carcinoma as measured by the Skindex-16 questionnaire [ Time Frame: 12 months ]
- Diagnostic suitability of non-invasive imaging techniques (in vivo confocal laserscan-microscopy and/or optical coherence tomography for the evaluation of response status of patients receiving vismodegib in the neoadjuvant setting) [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035188
|SRH Wald-Klinikum Gera GmbH|
|Gera, Thuringia, Germany, 07548|
|Klinikum Augsburg Süd|
|Augsburg, Germany, 86179|
|Charité - Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Elbe Kliniken Stade - Buxtehude GmbH|
|Buxtehude, Germany, 21614|
|Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden|
|Dresden, Germany, 01307|
|HELIOS Klinikum Erfurt|
|Erfurt, Germany, 99089|
|Leipzig, Germany, 04103|
|Münster, Germany, 48149|
|Münster, Germany, 48157|
|Klinikum Nürnberg Nord|
|Nürnberg, Germany, 90419|
|Harzklinikum Dorothea Christiane Erxleben GmbH|
|Quedlinburg, Germany, 06484|
|Tübingen, Germany, 72076|
|Principal Investigator:||Martin Kaatz, PD Dr.||firstname.lastname@example.org|