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Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma (NICCI)

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ClinicalTrials.gov Identifier: NCT03035188
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
SRH Wald-Klinikum Gera GmbH

Brief Summary:

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Arm Intervention/treatment
Experimental: Vismodegib
Continuous once-daily oral dosing of vismodegib at a dosage of 150 mg per administration
Drug: Vismodegib
1 capsule (150 mg vismodegib) taken once daily for a maximum of 12 weeks.
Other Name: Erivedge




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
  2. Duration of overall response (DoR) [ Time Frame: 12 months ]
    Time from documented CR, PR or SD until progression of disease

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]
  4. 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 ]

Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patient aged ≥ 18 years
  2. Able to participate and willing to give written informed consent including consent for photographs prior to performance of study-related procedures and to comply with the study protocol.
  3. Patients with at least 1 large (≥ 2 cm in diameter in head/neck region, ≥ 5 cm for trunk/extremities) basal cell carcinoma (BCC), still resectable, but with increased risk for cosmetic disfigurement or functional defects by assessment of the enrolling physician. Patients with large (as defined above) recurrent basal cell carcinoma are also eligible.
  4. Patients must be naïve to treatment with vismodegib or other hedgehog pathway inhibitors
  5. Local histopathologic confirmation of BCC (3 mm punch biopsy)
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  7. Consent to undergo mapping biopsies upon reaching complete response

    Adequate hematologic and organ function, defined by the following laboratory results, to be obtained within 7 days prior to registration and prior to first dose of study drug treatment:

    • Absolute neutrophilic count > 1,0 x 109/L
    • Platelet count ≥ 75 x 109/L
    • Hemoglobin ≥ 8,5 g/dL
    • Albumin ≥ 2.5 g/dL
    • Bilirubin ≤ 1.5 x the upper limit of normal (ULN) or within 3 x ULN for patients
    • Aspartate-aminotransferase, Alanine-aminotransferase, and alkaline phosphatase ≤ 3 x ULN
    • Serum creatinine ≤ 1.5 x ULN
  8. Female patients of childbearing potential must agree to always use 2 effective forms of contraception including one highly effective method and a barrier method during treatment with study medication and for 24 months after the final dose. Male patients with partners of childbearing potential must always use a condom (with spermicide, if available), even after a vasectomy, during treatment with study medication and for at least 2 months after the final dose. Breast feeding is likewise not allowed for at least 24 months after completion of study therapy.
  9. Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential (including pre-menopausal women with tubal ligation).
  10. Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and follow-up as defined by the treatment discontinuation schedule.
  11. Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of vismodegib. Because vismodegib has been detected in seminal fluid, in addition for men, agreement not donate sperm during the study or for at least 2 months after discontinuation of therapy
  12. Optional: Consent to undergo non-invasive imaging examinations by means of confocal laserscan-microscopy (CLSM) and/or optical coherence tomography (OCT), during and after end of study treatment.

Exclusion Criteria:

  1. History of prior treatment with vismodegib or any other hedgehog pathway inhibitor.
  2. Radiotherapy that involved the field of the target lesion within 6 months prior to registration. Only one radiotherapy of the target lesion performed > 6 months prior to registration is allowed. If a second radiotherapy in this field took place, patient will be excluded.
  3. Any metastatic BCC
  4. BCC lesion that is considered to be inoperable (e.g. medical contraindication to surgery, suspicion of bone infiltration)
  5. Metatypic BCC
  6. Known or suspected Gorlin-Goltz syndrome
  7. Uncontrolled medical illness, including advanced malignancies (no activities of the malignancies in the past 3 years), at the discretion of the Investigator
  8. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications
  9. History (within 6 months prior to registration) or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  10. Any medical or psychological illness or condition preventing adequate consent or ability to comply with the protocol
  11. Inability or unwillingness to swallow capsules
  12. Inability or unwillingness to comply with study and follow-up procedures
  13. Current severe, uncontrolled systemic disease
  14. History of malabsorption or other conditions that would interfere with the absorption of the orally applicated study drug
  15. Pregnant, lactating, or breast feeding women
  16. Patients with one of the following rare hereditary conditions: galactose intolerance, primary hypolactasia, or glucose-galactose malabsorption
  17. Participation in another clinical study within 28 days before registration or within a time period of five elimination half-lives of the slowest eliminated previously used study drug (whichever is the longest time period).
  18. Known or suspected alcohol or drug abuse in the opinion of the investigator
  19. Known hypersensitivity reaction to vismodegib or any of the other ingredients of this medicine
  20. Treatment with St John's wort (Hypericum perforatum)

Information from the National Library of Medicine

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


Contacts
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Contact: Claudia Deumer, Dr. claudia.deumer@srh.de

Locations
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Germany
SRH Wald-Klinikum Gera GmbH Recruiting
Gera, Thuringia, Germany, 07548
Contact: Claudia Deumer, Dr.    +49365828 ext 7758    claudia.deumer@srh.de   
Principal Investigator: Martin Kaatz, PD Dr.         
Sub-Investigator: Sabine Sell         
Klinikum Augsburg Süd Recruiting
Augsburg, Germany, 86179
Principal Investigator: Julia Welzel, Prof. Dr.         
Sub-Investigator: Kai-Uwe Krämer, Dr.         
Sub-Investigator: Katharina Siedlecki, Dr. med.         
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Principal Investigator: Claas Ulrich, Dr. med.         
Sub-Investigator: Felix Kiecker, Dr. med.         
Elbe Kliniken Stade - Buxtehude GmbH Not yet recruiting
Buxtehude, Germany, 21614
Principal Investigator: Peter Mohr, Dr. med.         
Sub-Investigator: Leonie Bluhm-Drude         
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden Recruiting
Dresden, Germany, 01307
Principal Investigator: Friedegund Meier, Prof. Dr.         
Sub-Investigator: Ricarda Rauschenberg, Dr. med.         
HELIOS Klinikum Erfurt Not yet recruiting
Erfurt, Germany, 99089
Principal Investigator: Rudolf A. Herbst, Prof. Dr.         
Sub-Investigator: Ivonne Kellner, Dr. med.         
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Principal Investigator: Jan C. Simon, Prof. Dr.         
Sub-Investigator: Mirjana Ziemer, PD Dr. med.         
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Principal Investigator: Carsten Weishaupt, Dr. med.         
Sub-Investigator: Nina Magnolo, Dr.         
Fachklinik Hornheide Recruiting
Münster, Germany, 48157
Principal Investigator: Hans-Joachim Schulze, PD Dr. med.         
Sub-Investigator: Susanne Dugas-Breit, Dr. med.         
Klinikum Nürnberg Nord Recruiting
Nürnberg, Germany, 90419
Principal Investigator: Dirk Debus, Dr. med.         
Sub-Investigator: Erwin S Schultz, Prof. Dr.         
Harzklinikum Dorothea Christiane Erxleben GmbH Not yet recruiting
Quedlinburg, Germany, 06484
Principal Investigator: Jens Ulrich, Prof. Dr.         
Sub-Investigator: Florian Joithe         
Sub-Investigator: André Kriesche, Dr.         
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Principal Investigator: Ulrike MB Leiter-Stöppke, PD Dr. med.         
Sub-Investigator: Thomas K. Eigentler, PD Dr. med.         
Sponsors and Collaborators
SRH Wald-Klinikum Gera GmbH
Investigators
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Principal Investigator: Martin Kaatz, PD Dr. martin.kaatz@wkg.srh.de

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SRH Wald-Klinikum Gera GmbH
ClinicalTrials.gov Identifier: NCT03035188     History of Changes
Other Study ID Numbers: ADO-EP02 (ML29328)
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by SRH Wald-Klinikum Gera GmbH:
resectable
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell