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 : Recruiting
First Posted : April 19, 2013
Last Update Posted : June 5, 2018
|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)|
|Estimated 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|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 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.
- Local-regional control from therapy completion [ Time Frame: 12 months after completing therapy ]To determine 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.
- Probability of progression-free survival [ Time Frame: From treatment start up to 12 months after completing therapy ]Failure is defined as any disease recurrence or death due to any cause, and OS with the duration for each measured from the time of first treatment with vismodegib to 12 months after completion of study treatment.
- Initial toxicity during the 3 months immediately after completion of protocol therapy. [ Time Frame: 3 months after completing therapy ]CTCAE grading of toxicity.
- Feasibility of administering concurrent vismodegib with radiation therapy [ Time Frame: up to 6 months from treatment start ]Determined by the proportion of patients discontinuing treatment due to toxicity during the study
- Response rate of the primary site and regionally involved areas following all treatment components [ Time Frame: at 3 months after the completion of protocol therapy. ]response per RECIST
- Clinical response to vismodegib and radiation therapy [ Time Frame: up to 12 months after completing therapy ]Number of patients with a decrease of basal cell carcinoma within the irradiated planning tumor volumes in patients who completed therapy, determined by investigator.
- Adverse events reported during the drug-alone and combined-modality components of the protocol regimen during treatment [ Time Frame: up to 12 months after completing therapy ]Assessed by the number and attribution of all adverse events (CTCAE, v 4.1) in patients who receive any amount of study drug and radiation therapy.
- Proportion of any adverse events (CTCAE, v. 4.1) assessed to be related during the drug-alone and combined-modality components of the protocol regimen during treatment [ Time Frame: up to 12 months after completing therapy ]CTCAE, v. 4.1 grading
- Proportion of patients experiencing Grade 4-5 adverse events related to the induction or concurrent treatment components of the protocol regimen (that is not definitely related to disease progression) [ Time Frame: up to 12 months after completing therapy ]CTCAE, v. 4.1 grading
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
|Contact: Sue Yomfirstname.lastname@example.org|
|Contact: Kyusun Chaemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Kyusun Cha 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Sue Yom, MD|
|Principal Investigator: Chris Barker, MD, PhD|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Ming Lian 212-639-8074 email@example.com|
|Principal Investigator:||Sue Yom, MD||University of California, San Francisco|