Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma
Chemotherapy, radiation therapy, and surgery are standard treatments for basal cell carcinoma at most institutions. The purpose of this study is to determine whether adding vismodegib to radiation (chemoradiotherapy) is safe and tolerable. The purpose of this study is to assess the safety and tolerability of combined radiation therapy and vismodegib. This combination may increase the chances of the tumors being destroyed or unable to spread to other parts of the body in people with locally advanced basal cell carcinoma of the head and neck.
Locally Advanced Basal Cell Carcinoma
Radiation: Radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Local-regional control from therapy completion [ Time Frame: About 18 months ] [ Designated as safety issue: No ]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: About 18 months ] [ Designated as safety issue: No ]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: About 3 months ] [ Designated as safety issue: Yes ]
- Feasibility of administering concurrent vismodegib with radiation therapy determined by the proportion of patients discontinuing treatment due to toxicity during the study [ Time Frame: About 6 months ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: About 3 months ] [ Designated as safety issue: No ]
- Clinical response to vismodegib and radiation therapy determined by the proportion of patients with a decrease of basal cell carcinoma within the irradiated planning tumor volumes in patients who completed therapy [ Time Frame: About 18 months ] [ Designated as safety issue: No ]
- Adverse events reported during the drug-alone and combined-modality components of the protocol regimen during treatment [ Time Frame: about 18 months ] [ Designated as safety issue: Yes ]This will be assessed by the number and attribution of all adverse events, (including vital signs, physical findings, and clinical laboratory results, 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: About 18 months ] [ Designated as safety issue: Yes ]
- 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: About 18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Vismodegib and Radiation Therapy
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: ErivedgeRadiation: 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.
This is a single arm, multi-centered Phase II clinical trial to assess the safety and demonstrate the efficacy of a combined modality approach using radiation therapy after induction and concurrently with systemic administration of vismodegib, which may increase the rates of complete response and sustained local control in patients with locally advanced BCC
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835626
|Contact: Romobia Hutchinson||415-353-4294||HutchinsonR@cc.ucsf.edu|
|Contact: Frances Zhang||415-353-9857||FZhang@radonc.ucsf.edu|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Romobia Hutchinson 415-353-4294 HutchinsonR@cc.ucsf.edu|
|Contact: Taylor Dunbar 415-353-9249 email@example.com|
|Principal Investigator: Sue Yom, MD|
|Sub-Investigator: Sarah Arron, MD, PhD|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York City, New York, United States, 10065|
|Contact: Ming Lian 212-639-8074 firstname.lastname@example.org|
|Principal Investigator:||Sue Yom, MD||University of California, San Francisco|