Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379470
Status:
COMPLETED
Last Update Posted:
2012-05-01
First Post:
2006-09-20
Brief Title:
Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme GBM
Sponsor:
NovoCure Ltd
Organization:
NovoCure Ltd
Study Overview
Official Title:
A Prospective Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a randomized controlled trial designed to test the efficacy and safety of a new medical device the NovoTTF-100A The device is an experimental portable battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme GBM using alternating electric fields termed TTFields
Detailed Description:
PAST CLINICAL EXPERIENCE
The effect of the electric fields generated by the NovoTTF-100A device TTFields has been tested in two pilot trials in humans The data from these trials suggest NovoTTF-100A may improve time to disease progression and overall survival of recurrent GBM patients Although the number of patients in the pilot trials is small The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with recurrent GBM
DESCRIPTION OF THE TRIAL
Patients with GBM whose disease has recurred or progressed despite standard treatment Surgery radiation therapy Temozolomide treatment and meet all of the requirements for participation in the study will be randomly assigned to one of two groups
1 Treatment with the NovoTTF-100A device or
2 Treatment with the best standard of care practiced at each of the participating centers
If assigned to the best standard of care group patients will receive a chemotherapeutic agent chosen based on their prior treatments and the standard of care practiced at each treating center
If assigned to the NovoTTF-100A group the patients will be treated continuously for as long as their disease is stable or regressing NovoTTF-100A treatment will consist of wearing four electrically insulated electrodes on the head Electrode placement will require shaving of the scalp before treatment After an initial short hospitalization 24 hours patients will be released to continue treatment at home where they can maintain their regular daily routine
During the trial regardless of whether assigned to the NovoTTF-100A treatment group or the best standard of care group patients will need to return once every month the hospital outpatient clinics where they will be examined by a physician and undergo routine laboratory examinations These routine visits will continue for as long as the patients disease is not progressing After progression if such occurs patients will need to return once per month for two more months to the outpatient clinic for similar follow up examinations
During the visits to the clinic patients will be examined physically and neurologically Additionally routine blood tests and ECG will be performed A routine MRI of the head will be performed at baseline and after 2 4 and 6 months After this follow up plan patients will be contacted once per month by telephone to answer basic questions about their health status
SCIENTIFIC BACKGROUND
Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field These forces cause movement and rotation of electrically charged biological building blocks much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet
Electric fields can also cause muscles to twitch and if strong enough may heat tissues TTFields are alternating electric fields of low intensity This means that they change their direction repetitively many times a second Since they change direction very rapidly 200 thousand times a second they do not cause muscles to twitch nor do they have any effects on other electrically activated tissues in the body brain nerves and heart Since the intensities of TTFields in the body are very low they do not cause heating
The breakthrough finding made by NovoCure was that finely tuned alternating fields of very low intensity now termed TTFields Tumor Treating Fields cause a significant slowing in the growth of cancer cells Due to the unique geometric shape of cancer cells when they are multiplying TTFields cause the building blocks of these cells to move and pile up in such a way that the cells physically explode In addition cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place TTFields cause these tiny motors to fall apart since they have a special type of electric charge
As a result of these two effects cancer tumor growth is slowed and can even reverse after continuous exposure to TTFields
Other cells in the body normal healthy tissues are affected much less than cancer cells since they multiply at a much slower rate if at all In addition TTFields can be directed to a certain part of the body leaving sensitive areas out of their reach
In conclusion TTField hold the promise of serving as a brand new cancer treatment with very few side effects and promising affectivity in slowing or reversing this disease
The effect of the electric fields generated by the NovoTTF-100A device TTFields has been tested in two pilot trials in humans The data from these trials suggest NovoTTF-100A may improve time to disease progression and overall survival of recurrent GBM patients Although the number of patients in the pilot trials is small The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with recurrent GBM
DESCRIPTION OF THE TRIAL
Patients with GBM whose disease has recurred or progressed despite standard treatment Surgery radiation therapy Temozolomide treatment and meet all of the requirements for participation in the study will be randomly assigned to one of two groups
1 Treatment with the NovoTTF-100A device or
2 Treatment with the best standard of care practiced at each of the participating centers
If assigned to the best standard of care group patients will receive a chemotherapeutic agent chosen based on their prior treatments and the standard of care practiced at each treating center
If assigned to the NovoTTF-100A group the patients will be treated continuously for as long as their disease is stable or regressing NovoTTF-100A treatment will consist of wearing four electrically insulated electrodes on the head Electrode placement will require shaving of the scalp before treatment After an initial short hospitalization 24 hours patients will be released to continue treatment at home where they can maintain their regular daily routine
During the trial regardless of whether assigned to the NovoTTF-100A treatment group or the best standard of care group patients will need to return once every month the hospital outpatient clinics where they will be examined by a physician and undergo routine laboratory examinations These routine visits will continue for as long as the patients disease is not progressing After progression if such occurs patients will need to return once per month for two more months to the outpatient clinic for similar follow up examinations
During the visits to the clinic patients will be examined physically and neurologically Additionally routine blood tests and ECG will be performed A routine MRI of the head will be performed at baseline and after 2 4 and 6 months After this follow up plan patients will be contacted once per month by telephone to answer basic questions about their health status
SCIENTIFIC BACKGROUND
Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field These forces cause movement and rotation of electrically charged biological building blocks much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet
Electric fields can also cause muscles to twitch and if strong enough may heat tissues TTFields are alternating electric fields of low intensity This means that they change their direction repetitively many times a second Since they change direction very rapidly 200 thousand times a second they do not cause muscles to twitch nor do they have any effects on other electrically activated tissues in the body brain nerves and heart Since the intensities of TTFields in the body are very low they do not cause heating
The breakthrough finding made by NovoCure was that finely tuned alternating fields of very low intensity now termed TTFields Tumor Treating Fields cause a significant slowing in the growth of cancer cells Due to the unique geometric shape of cancer cells when they are multiplying TTFields cause the building blocks of these cells to move and pile up in such a way that the cells physically explode In addition cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place TTFields cause these tiny motors to fall apart since they have a special type of electric charge
As a result of these two effects cancer tumor growth is slowed and can even reverse after continuous exposure to TTFields
Other cells in the body normal healthy tissues are affected much less than cancer cells since they multiply at a much slower rate if at all In addition TTFields can be directed to a certain part of the body leaving sensitive areas out of their reach
In conclusion TTField hold the promise of serving as a brand new cancer treatment with very few side effects and promising affectivity in slowing or reversing this disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None