Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT01835626|
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Basal Cell Carcinoma Skin Cancer Cutaneous Malignancy||Drug: Vismodegib Radiation: Radiation therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Radiation Therapy and Vismodegib, for the Treatment of Locally Advanced Basal Cell Carcinoma of the Head and Neck|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 10, 2019|
|Actual Study Completion Date :||September 10, 2019|
Experimental: Vismodegib and Radiation Therapy
150mg Vismodegib will be taken once a day, daily. Radiation therapy will be started after the patient has completed taking vismodegib for 12 weeks. The patient will take daily vismodegib through the completion of radiation therapy. The patient will receive radiation once a day, Monday through Friday, for 7 weeks. Each radiation treatment may take up to 30 minutes.
Vismodegib will be taken daily for 12 weeks. It should be taken at approximately the same time each day. Patients will be given a supply of vismodegib on Week 1, Day 1 to last until their next study visit. They will be asked to keep a record of each dose of vismodegib you take. After 12 weeks, they will be evaluated again to make sure they are still eligible to participate in the study. If they are eligible to continue, they will continue taking vismodeib daily as before for another 7 weeks while they receive radiation therapy.
Other Name: Erivedge
Radiation: Radiation therapy
Radiation therapy will be started after the patient has finished taking vismodegib for 12 weeks. They will receive radiation once a day, Monday through Friday, for 7 weeks. Each radiation treatment may take up to 30 minutes.
- Percentage of Patients With Local-regional Control Rate [ Time Frame: Up to 12 months after completing therapy ]The local-regional control rate at 12 months from protocol therapy completion, defined as complete or partial response, with absence of progressive disease within the irradiated planning tumor volumes (PTV) for patients with locally advanced basal cell carcinoma in the head and neck.
- Progression-Free Survival (PFS) [ Time Frame: From treatment start up to 12 months after completing therapy ]Estimate of the probability of PFS, with failure defined as any disease recurrence or death due to any cause with each duration measured from the time of first treatment with vismodegib to 12 months after completion of study treatment
- Overall Survival (OS) [ Time Frame: From treatment start up to 12 months after completing therapy ]Estimate of the probability of OS, with failure defined as any disease recurrence or death due to any cause with each duration measured from the time of first treatment with vismodegib to 12 months after completion of study treatment
- Percentage of Patients by Treatment-Related Adverse Events by Event Description [ Time Frame: up to 12 months after completing therapy ]The percentage of any adverse events (CTCAE, v. 4.0) assessed to be definitely, probably, or possibly related to vismodegib or its combination with radiation therapy at any point during protocol therapy or during the followup period.
- Percentage of Patients by Adverse Event Not Related to Disease Progression [ Time Frame: up to 12 months after completing therapy ]The percentage of patients experiencing Grade 4-5 adverse events classified using CTCAE v.4.1 assessed to be definitely, probably, or possibly related to the induction or concurrent treatment components of the protocol regimen (that is not definitely related to disease progression) at any point during protocol therapy or during the followup period
- Number of Patients Discontinuing Treatment Due to Toxicity [ Time Frame: up to 6 months from treatment start ]Feasibility of administering concurrent vismodegib with radiation therapy was assessed by the number of patients discontinuing treatment due to toxicity during the concurrent administration of vismodegib and radiation therapy (<75% of planned radiation therapy delivered)
- Clinical Response Rate [ Time Frame: Up to 12 months after completing therapy ]Response rate (as per RECIST) of the primary site and regionally involved areas following all treatment components at 3 months after the completion of protocol therapy will be reported as a percentage of the total sample.
- Percentage of Patients With a Decrease of Basal Cell Carcinoma (BCC) [ Time Frame: Up to 12 months after completing therapy ]Proportion of patients with a decrease of BCC within the irradiated planning tumor volumes (PTV) in patients who complete initial combined therapy, indicating a clinical response to vismodegib and radiation therapy
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): NCT01835626
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Sue Yom, MD||University of California, San Francisco|