Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01756729
Status:
TERMINATED
Last Update Posted:
2016-03-02
First Post:
2012-12-20
Brief Title:
Post-approval Study of NovoTTF-100A in Recurrent GBM Patients
Sponsor:
NovoCure Ltd
Organization:
NovoCure Ltd
Study Overview
Official Title:
A Prospective Non-randomized Concurrent Control Open Label Post-approval Study of NovoTTF-100A in Recurrent GBM Patient
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Amendment of Study Protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-randomized concurrent control study designed to confirm that the efficacy of the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings following approval is comparable to that of BSC chemotherapy patients The device is a portable battery operated device that was approved for the treatment of adult patients 22 years of age or older with histologically-confirmed glioblastoma multiforme GBM following histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy The device is intended to be used as a monotherapy and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted
Detailed Description:
PAST CLINICAL EXPERIENCE
The effect of the electric fields generated by the NovoTTF-100A device TTFields TTF has been tested in a large prospective randomized trial in 237 recurrent GBM patients The outcome of subjects treated with the NovoTTF-100A device was compared to those treated with an effective best standard of care chemotherapy including bevacizumab NovoTTF-100A subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today Similar results showing comparability of NovoTTF-100A to BSC chemotherapy were seen in all secondary endpoints
Recurrent GBM patients treated with the NovoTTF-100A device in this trial experienced fewer side effects in general significantly fewer treatment related side effects and significantly lower gastrointestinal hematological and infectious adverse events compared to controls The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes Finally quality of life measures were better in NovoTTF-100A subjects as a group when compared to subjects receiving effective best standard of care chemotherapy
DESCRIPTION OF THE TRIAL
Patients with GBM whose disease has first recurred despite standard treatment Surgery radiation therapy Temozolomide treatment and meet all of the requirements for participation in the study will be recruited to one of two groups based on patient preference alone
1 Treatment with the NovoTTF-100A device or
2 Treatment with the best standard of care practiced at each of the participating centers
If recruited 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 recruited to the NovoTTF-100A group the patients will be treated continuously until tumor progression NovoTTF-100A treatment will consist of wearing four electrically insulated electrodes on the head Electrode placement will require shaving of the scalp before treatment Patients will 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 These routine visits will continue for as long as the patients disease is not progressing
During the visits to the clinic patients will be examined physically and neurologically as well as fill in neuro-cognitive questionnaires Adverse events data will be collected from all patients After this follow up plan patients will be contacted once per month by telephone to answer basic questions about their health status
SCIENTIFIC BACKGROUND
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 TTF has been tested in a large prospective randomized trial in 237 recurrent GBM patients The outcome of subjects treated with the NovoTTF-100A device was compared to those treated with an effective best standard of care chemotherapy including bevacizumab NovoTTF-100A subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today Similar results showing comparability of NovoTTF-100A to BSC chemotherapy were seen in all secondary endpoints
Recurrent GBM patients treated with the NovoTTF-100A device in this trial experienced fewer side effects in general significantly fewer treatment related side effects and significantly lower gastrointestinal hematological and infectious adverse events compared to controls The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes Finally quality of life measures were better in NovoTTF-100A subjects as a group when compared to subjects receiving effective best standard of care chemotherapy
DESCRIPTION OF THE TRIAL
Patients with GBM whose disease has first recurred despite standard treatment Surgery radiation therapy Temozolomide treatment and meet all of the requirements for participation in the study will be recruited to one of two groups based on patient preference alone
1 Treatment with the NovoTTF-100A device or
2 Treatment with the best standard of care practiced at each of the participating centers
If recruited 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 recruited to the NovoTTF-100A group the patients will be treated continuously until tumor progression NovoTTF-100A treatment will consist of wearing four electrically insulated electrodes on the head Electrode placement will require shaving of the scalp before treatment Patients will 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 These routine visits will continue for as long as the patients disease is not progressing
During the visits to the clinic patients will be examined physically and neurologically as well as fill in neuro-cognitive questionnaires Adverse events data will be collected from all patients After this follow up plan patients will be contacted once per month by telephone to answer basic questions about their health status
SCIENTIFIC BACKGROUND
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