Ignite Creation Date:
2024-05-05 @ 9:35 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00916409
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2009-06-05
Brief Title:
Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme GBM
Sponsor:
NovoCure Ltd
Organization:
NovoCure Ltd
Study Overview
Official Title:
A Prospective Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM
Status:
COMPLETED
Status Verified Date:
2017-04
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 prospective randomly controlled pivotal trial designed to test the efficacy and safety of a medical device the NovoTTF-100A as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients The device is an experimental portable battery operated device for chronic administration of alternating electric fields termed TTFields or TTF to the region of the malignant tumor by means of surface insulated electrode arrays
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 recurrent GBM 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
In a small scale pilot trial in newly diagnosed GBM patients the treatment was well tolerated and suggested that NovoTTF-100A may improve time to disease progression and overall survival of newly diagnosed GBM patients Although the number of patients in the pilot trial was small The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with newly diagnosed GBM
DESCRIPTION OF THE TRIAL
All patients included in this trial are newly diagnosed GBM patients who underwent a biopsy or surgery with or without Gliadel wafers followed by radiation therapy in combination with Temozolomide chemotherapy In addition all patients must meet all eligibility criteria
Eligible patients will be randomly assigned to one of two groups
1 Treatment with the NovoTTF-100A device in combination with Temozolomide chemotherapy
2 Treatment with Temozolomide alone as the best known standard of care
Patients will be randomized at a 21 ratio 2 of every three patients who participate in the trial will be treated with the NovoTTF-100A device Baseline tests will be performed in patients enrolled in both arms including specific genetic tests done using tumor samples obtained during their initial surgery If assigned to the NovoTTF-100A in combination with Temozolomide group the patients will be treated continuously with the device until second progression They will also receive temozolomide and possibly a second line treatment that can be one of the following re-operation local radiotherapy gamma-knife a second line of chemotherapy or a combination of the above
NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head Electrode array placement will require shaving of the scalp before and frequently during the treatment After an initial short visit to the clinic for training and monitoring patients will be released to continue treatment at home where they can maintain their regular daily routine
During the trial regardless of which treatment group the patient was assigned to he or she will need to return once every month to the clinic where an examination by a physician and a routine laboratory examinations will be done These routine visits will continue for as long as the patients disease is not progressing for the second time under the study treatment If such occurs patients will need to return once per month for two more months to the clinic for similar follow up examinations
During the visits to the clinic patients will be examined physically and neurologically Additionally routine blood tests will be performed A routine MRI of the head will be performed at baseline and every second month thereafter until second progression 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 TTF has been tested in a large prospective randomized trial in recurrent GBM 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
In a small scale pilot trial in newly diagnosed GBM patients the treatment was well tolerated and suggested that NovoTTF-100A may improve time to disease progression and overall survival of newly diagnosed GBM patients Although the number of patients in the pilot trial was small The FDA has determined that the data gathered so far warrant testing of NovoTTF-100A treatment as a possible therapy for patients with newly diagnosed GBM
DESCRIPTION OF THE TRIAL
All patients included in this trial are newly diagnosed GBM patients who underwent a biopsy or surgery with or without Gliadel wafers followed by radiation therapy in combination with Temozolomide chemotherapy In addition all patients must meet all eligibility criteria
Eligible patients will be randomly assigned to one of two groups
1 Treatment with the NovoTTF-100A device in combination with Temozolomide chemotherapy
2 Treatment with Temozolomide alone as the best known standard of care
Patients will be randomized at a 21 ratio 2 of every three patients who participate in the trial will be treated with the NovoTTF-100A device Baseline tests will be performed in patients enrolled in both arms including specific genetic tests done using tumor samples obtained during their initial surgery If assigned to the NovoTTF-100A in combination with Temozolomide group the patients will be treated continuously with the device until second progression They will also receive temozolomide and possibly a second line treatment that can be one of the following re-operation local radiotherapy gamma-knife a second line of chemotherapy or a combination of the above
NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head Electrode array placement will require shaving of the scalp before and frequently during the treatment After an initial short visit to the clinic for training and monitoring patients will be released to continue treatment at home where they can maintain their regular daily routine
During the trial regardless of which treatment group the patient was assigned to he or she will need to return once every month to the clinic where an examination by a physician and a routine laboratory examinations will be done These routine visits will continue for as long as the patients disease is not progressing for the second time under the study treatment If such occurs patients will need to return once per month for two more months to the clinic for similar follow up examinations
During the visits to the clinic patients will be examined physically and neurologically Additionally routine blood tests will be performed A routine MRI of the head will be performed at baseline and every second month thereafter until second progression 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