Recurrent Glioblastoma MultiformePhase 4NCT01756729
Post-approval Study of NovoTTF-100A in Recurrent GBM Patients
A Phase 4 study testing NovoTTF-100A in people with Recurrent Glioblastoma Multiforme, run by NovoCure Ltd. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Recurrent Glioblastoma Multiforme
- What is being tested?
- NovoTTF-100A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2012to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 years of age or older
- Histological diagnosis of GBM (WHO grade IV)
- Tumor located in the supra-tentorial region of the brain
- Received maximal, safe, surgical resection
- Received maximal radiation therapy
- Received concomitant Temozolomide
Show all 14Show fewer
- Received maintenance Temozolomide
- First recurrence (based on radiological or histological evidence of recurrence)
- Karnofsky performance score 70 or above
- MMSE score 25 or above
- Adequate amount and quality of tumor tissue from first surgical resection available for genetic profiling
- Women of childbearing age must be on effective contraception
- Signed informed consent
- Stable steroid dose in past 4 weeks
Who cannot join
- Implanted electronic medical device in the brain:
- Deep brain stimulator
- Vagus nerve stimulator
- Programmable shunt
- Skull defect without replacement
- Unable to comply with treatment with the NovoTTF-100A device
Show all 15Show fewer
- Pregnant
- Prior antiangiogenic therapy (e.g., Bevacizumab/Avastin)
- Second or subsequent recurrence
- Any prior cytotoxic chemotherapy except Temozolomide
- Actively participating in another therapeutic clinical trial
- Radiological suspicion of pseudoprogression or radionecrosis
- Radiation therapy or surgery in the past 4 weeks
- Unable to comply with the study follow-up schedule
- Any serious co-morbidity which is expected to affect survival more adversely than GBM
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0111
University of Illinois at Chicago
Chicago, Illinois, 60612
Baylor Research Institute
Dallas, Texas, 75246
Geisinger Health System
Danville, Pennsylvania, 17822
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
The Long Island Brain Tumor Center
Lake Success, New York, 11042
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536-0093
Keck Medical Center of USC
Los Angeles, California, 90033
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Barrow Neurology Clinics
Phoenix, Arizona, 85013
Washington University School of Medicine, Division of Oncology
St Louis, Missouri, 63110
About this study
Official title: A Prospective, Non-randomized, Concurrent Control, Open Label, Post-approval Study of NovoTTF-100A in Recurrent GBM Patient
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.
Read the 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:
- Treatment with the NovoTTF-100A device, or
- 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 patient's 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.
- Conditions
- Recurrent Glioblastoma Multiforme
- Being tested
- NovoTTF-100A
- Keywords
- Brain tumor, Treatment, Minimal toxicity, GBM, Glioblastoma, Recurrent, TTFields
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-100ADevice
Multiple four-week courses of continuous NovoTTF-100A treatment.
| Study group | Role | What they receive |
|---|---|---|
| Best Standard of Care | Active comparator | Patients recruited to the BSC group will be treated according to the BSC practiced at each center. Receives: Device: NovoTTF-100A |
| NovoTTF-100A (monotherapy) | Experimental | Patients will be treated continuously with the NovoTTF-100A device. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine. Receives: Device: NovoTTF-100A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 5 years from initiation of accrual
Secondary outcomes (3)
Change in neuro-cognitive function from baseline based on MMSE
Measured: 5 years from initiation of accrual
Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment
Measured: 5 years from initiation of accrual
Adverse events severity and frequency
Measured: 5 years from initiation of accrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Amendment of Study Protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Recurrent Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoCure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert Engelhard, MD, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756729
- Sponsor's protocol ID
- EF-19
- Status last verified
- Feb 2016
- First submitted
- 20 Dec 2012
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.
PubMed 15126372Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.
PubMed 17551011Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.
PubMed 22608262Zhu JJ, Goldlust SA, Kleinberg LR, Honnorat J, Oberheim Bush NA, Ram Z. Tumor Treating Fields (TTFields) therapy vs physicians' choice standard-of-care treatment in patients with recurrent glioblastoma: a post-approval registry study (EF-19). Discov Oncol. 2022 Oct 14;13(1):105. doi: 10.1007/s12672-022-00555-5.
PubMed 36239858
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Concurrent Control, Open Label, Post-approval Study of NovoTTF-100A in Recurrent GBM Patient
- ClinicalTrials.gov ID
- NCT01756729
- Acronym / sponsor ID
- EF-19
- Conditions
- Recurrent Glioblastoma Multiforme
- Keywords
- Brain tumor, Treatment, Minimal toxicity, GBM, Glioblastoma, Recurrent, TTFields
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amendment of Study Protocol
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NovoCure Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 27 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Treatment with the NovoTTF-100A device, or
- 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 patient's 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Standard of Care | Active comparator | Device: NovoTTF-100APatients recruited to the BSC group will be treated according to the BSC practiced at each center. |
| NovoTTF-100A (monotherapy) | Experimental | Device: NovoTTF-100APatients will be treated continuously with the NovoTTF-100A device. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 22 years of age or older
- Histological diagnosis of GBM (WHO grade IV)
- Tumor located in the supra-tentorial region of the brain
- Received maximal, safe, surgical resection
- Received maximal radiation therapy
Key exclusion criteria (15 listed)
- Implanted electronic medical device in the brain:
- Skull defect without replacement
- Unable to comply with treatment with the NovoTTF-100A device
- Pregnant
- Prior antiangiogenic therapy (e.g., Bevacizumab/Avastin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoTTF-100AMultiple four-week courses of continuous NovoTTF-100A treatment. | Device | Best Standard of Care, NovoTTF-100A (monotherapy) |
Primary outcome
Overall Survival
Time frame: 5 years from initiation of accrual
3 secondary outcomes
Change in neuro-cognitive function from baseline based on MMSE
Time frame: 5 years from initiation of accrual
Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment
Time frame: 5 years from initiation of accrual
Adverse events severity and frequency
Time frame: 5 years from initiation of accrual
Results and safety
The study was stopped early (reason given: Amendment of Study Protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Background: PubMed 15126372Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.
- Background: PubMed 17551011Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.
- Background: PubMed 22608262Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.
- Derived from this study: PubMed 36239858Zhu JJ, Goldlust SA, Kleinberg LR, Honnorat J, Oberheim Bush NA, Ram Z. Tumor Treating Fields (TTFields) therapy vs physicians' choice standard-of-care treatment in patients with recurrent glioblastoma: a post-approval registry study (EF-19). Discov Oncol. 2022 Oct 14;13(1):105. doi: 10.1007/s12672-022-00555-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Engelhard, MD, PhD principal investigator
University of Illinois Chicago
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NovoTTF-100A in people with Recurrent Glioblastoma Multiforme, run by NovoCure Ltd. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Amendment of Study Protocol). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 5 years from initiation of accrual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01756729, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.