Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01835626
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Sue Yom, University of California, San Francisco

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Locally Advanced Basal Cell Carcinoma
Skin Cancer
Cutaneous Malignancy
Interventions Drug: Vismodegib
Radiation: Radiation therapy
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description 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. 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.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
50-59 years old
5
  20.8%
60-69 years old
8
  33.3%
70-79 years old
4
  16.7%
80-89 years old
6
  25.0%
90-99 years old
1
   4.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
6
  25.0%
Male
18
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
  62.5%
Unknown or Not Reported
9
  37.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
  58.3%
More than one race
0
   0.0%
Unknown or Not Reported
9
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Percentage of Patients With Local-regional Control Rate
Hide Description 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.
Time Frame Up to 12 months after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description:
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. 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.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage
100
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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
Time Frame From treatment start up to 12 months after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description:
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. 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.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: probability of progression-free survival
1.00
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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
Time Frame From treatment start up to 12 months after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description:
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. 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.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: probability of survival
1.00
4.Secondary Outcome
Title Percentage of Patients by Treatment-Related Adverse Events by Event Description
Hide Description 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.
Time Frame up to 12 months after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description:
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. 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.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of patients
Grade 4 eye disorder 4
Grade 3 hyponatremia 13
Grade 3 oral mucositis 8
Grade 3 Gastrointestinal disorder 8
Grade 3 Dermatologic disorder 8
Grade 3 Abnormal Liver function 4
Grade 3 Anemia 4
Grade 3 Hypertension 4
Grade 2 Dermatitis 33
Grade 2 Dysgeusia 33
Grade 2 Myalgia 25
Grade 2 Fatigue 21
Grade 2 Oral mucositis 21
Grade 2 Weight Loss 17
5.Secondary Outcome
Title Percentage of Patients by Adverse Event Not Related to Disease Progression
Hide Description 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
Time Frame up to 12 months after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 patient experienced an adverse event (Grade 4 Eye Disorder) not related to disease progression
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description:
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. 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.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage of participants
6
6.Secondary Outcome
Title Number of Patients Discontinuing Treatment Due to Toxicity
Hide Description 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)
Time Frame up to 6 months from treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description:
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. 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.
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
5
  20.8%
7.Secondary Outcome
Title Clinical Response Rate
Hide Description 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.
Time Frame Up to 12 months after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description:
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. 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.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage of patients
88
8.Secondary Outcome
Title Percentage of Patients With a Decrease of Basal Cell Carcinoma (BCC)
Hide Description 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
Time Frame Up to 12 months after completing therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description:
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. 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.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage of patients
88
Time Frame Up to 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vismodegib and Radiation Therapy
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Vismodegib and Radiation Therapy
Affected / at Risk (%)
Total   1/24 (4.17%)    
Hide Serious Adverse Events
Vismodegib and Radiation Therapy
Affected / at Risk (%) # Events
Total   4/24 (16.67%)    
Eye disorders   
Corneal ulcer  1  1/24 (4.17%)  1
Gastrointestinal disorders   
Gastric hemorrhage  1  1/24 (4.17%)  1
Metabolism and nutrition disorders   
Hyponatremia  1  2/24 (8.33%)  2
Vascular disorders   
Abdominal Aortic Aneurysm  1  1/24 (4.17%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vismodegib and Radiation Therapy
Affected / at Risk (%) # Events
Total   24/24 (100.00%)    
Cardiac disorders   
Palpitations  1  2/24 (8.33%)  2
Eye disorders   
Blurred vision  1  2/24 (8.33%)  2
Dry eye  1  2/24 (8.33%)  2
Eye disorders - Other  1  2/24 (8.33%)  3
Gastrointestinal disorders   
Mucositis oral  1  8/24 (33.33%)  16
Dry mouth  1  5/24 (20.83%)  8
Nausea  1  5/24 (20.83%)  6
Constipation  1  4/24 (16.67%)  4
Diarrhea  1  2/24 (8.33%)  3
Dysphagia  1  2/24 (8.33%)  2
General disorders   
Fatigue  1  19/24 (79.17%)  26
General disorders and administration site conditions - other  1  4/24 (16.67%)  12
Edema face  1  2/24 (8.33%)  2
Facial pain  1  2/24 (8.33%)  2
Injury, poisoning and procedural complications   
Dermatitis radiation  1  11/24 (45.83%)  18
Investigations   
Weight loss  1  10/24 (41.67%)  13
Alanine aminotransferase increased  1  2/24 (8.33%)  2
Creatinine increased  1  2/24 (8.33%)  3
Metabolism and nutrition disorders   
Anorexia  1  7/24 (29.17%)  9
Hypokalemia  1  2/24 (8.33%)  2
Hyponatremia  1  3/24 (12.50%)  9
Musculoskeletal and connective tissue disorders   
Myalgia  1  18/24 (75.00%)  22
Superficial soft tissue fibrosis  1  2/24 (8.33%)  2
Trismus  1  2/24 (8.33%)  2
Nervous system disorders   
Dysgeusia  1  19/24 (79.17%)  30
Headache  1  4/24 (16.67%)  4
Peripheral sensory neuropathy  1  4/24 (16.67%)  5
Dizziness  1  2/24 (8.33%)  2
Memory impairment  1  2/24 (8.33%)  4
Psychiatric disorders   
Depression  1  2/24 (8.33%)  2
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  4/24 (16.67%)  5
Cough  1  3/24 (12.50%)  3
Nasal Congestion  1  2/24 (8.33%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  9/24 (37.50%)  9
Pruritus  1  4/24 (16.67%)  5
Pain of skin  1  2/24 (8.33%)  2
Vascular disorders   
Hypertension  1  4/24 (16.67%)  5
Hypotension  1  2/24 (8.33%)  2
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sue Yom
Organization: University of California, San Francisco
Phone: (415) 353-9893
EMail: Sue.Yom@ucsf.edu
Layout table for additonal information
Responsible Party: Sue Yom, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01835626    
Other Study ID Numbers: 122011
NCI-2013-00871 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Submitted: April 10, 2013
First Posted: April 19, 2013
Results First Submitted: September 11, 2020
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020