GlioblastomaPhase 1NCT03705351
Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM
A Phase 1 study testing Tumor Treating Fields, Temozolomide and Radiation Therapy in people with Glioblastoma and Cancer of Brain, run by Providence Health & Services at 2 sites in United States.
Trial summary
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glioblastoma, Cancer of Brain, Glioblastoma Multiforme
- What is being tested?
- Tumor Treating Fields, Temozolomide and Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Dec 2019to 24 Feb 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- GBM or Gliosarcoma by histology
- MGMT methylation status and IDH mutation status must be assessed at the study site or patient's referral center. MGMT status will be used for stratification purposes but will not exclude patients from this study if they are either methylated, unmethylated, or indeterminate, or in process at the time of enrollment. Similarly, subjects with tumors that are IDH mutated or wild type are both eligible.
- Supratentorial location
- Maximum safe resection (including patients who can only safely be biopsied)
- 22 years of age or older
- Estimated survival of at least 12 weeks
Show all 12Show fewer
- KPS 70% or greater at time of entry to study
- Patient provided written informed consent, or provided by a legally authorized representative
- Willingness to comply with all procedures, including visits or evaluations, imaging, laboratory tests and rescue measures
- Acceptable method of birth control (see appendix)
- Have had a contrast-enhanced brain MRI after tumor resection procedure. If biopsy alone performed, cranial CT may be used in place of MRI, only if the patient had a preoperative MRI scan within 14 days of the biopsy.
- The following time period must have elapsed prior to study enrollment: 3-6 weeks (21-42 days) from time of definitive surgery or 2-4 weeks (14-28 days) from the time of biopsy, for those who were only able to safely have a biopsy and not full resection.
Who cannot join
- Craniotomy or stereotactic biopsy wound dehiscence or infection
- Known by history to be HIV positive or to have an AIDS-related illness, active Hepatitis B, or active Hepatitis C (testing not required)
- Presence of skull defects (bullets, metal fragments, missing bone)
- Patients with implanted electronic medical devices (including but not limited to: pacemaker, vagal nerve stimulator, or pain stimulator)
- Prior invasive malignancy, unless disease free for 3 or more years, with the exception of basal cell carcinoma, cervical carcinoma in situ, or melanoma in situ
- Recurrent malignant gliomas or higher grade gliomas transformed from previous low grade (II) glioma
Show all 25Show fewer
- Patients with any current Primary brain stem or spinal cord tumor
- Prior use of temozolomide
- Prior treatment with Avastin
- Individuals requiring >8mg of dexamethasone per day within 7 days prior to Day 1 (high dose steroid taper following craniotomy with >8mg of dexamethasone is allowed during the screening period, but subjects must taper down to 8mg or less of dexamethasone (or bioequivalent) within 7 days prior to Day 1).
- Clinically significant lab abnormalities at screening showing bone marrow, hepatic, and renal dysfunction:
- Thrombocytopenia (platelet count < 100 x 103/μL)
- Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
- Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
- Total bilirubin > upper limit of normal
- Significant renal impairment (serum creatinine > 1.7 mg/dL)
- CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting) at screening
- Inability to swallow pills
- Clinically significant or unstable comorbid medical condition, per investigator discretion (for example, active or uncontrolled infection requiring systemic therapy, including known HIV or hepatitis B or C virus)
- Known current alcohol or drug abuse, per investigator discretion. Prior history of substance abuse is permissible if subject has been sober for the past 3 years.
- Any clinically significant psychiatric condition that would prohibit patient willingness or ability to successfully complete study procedures, per investigator discretion
- Patients with an allergy to or an inability to have gadolinium contrast dye administered with MRI
- Patients with aneurysm clips or implanted metal objects in the brain
- Patients with significant skin breakdown on the scalp
- Patients who cannot receive standard of care radiation therapy and can only receive hypofractionated radiation due to age and poor performance status , per investigator discretion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence St. Vincent Medical Center
Portland, Oregon, 97225
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity)
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.
Read the detailed description
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.
The expected toxicity is skin related, and patients will be followed closely with weekly skin and neurological examinations during radiation therapy and for 8 weeks afterwards to capture any delayed toxicity as they begin adjuvant therapy per routine treatment. As long as study treatment is tolerated and their conditions remain stable, patients will continue the treatment for up to 24 months.
Prior to enrollment, an exploratory analysis of radiation dosimetry will be performed by phantom modeling incorporating the Optune arrays. The study incorporates three stages of recruitment to confirm the safety of combining tumor treating fields therapy with concurrent chemoradiation: a safety lead-in cohort of the first 6 patients enrolled, a second safety lead-in cohort of 9 patients, and an expansion cohort with 15 additional patients.
- Conditions
- Glioblastoma, Cancer of Brain, Glioblastoma Multiforme, Brain Tumor
- Being tested
- Tumor Treating Fields, Temozolomide, Radiation Therapy
- Keywords
- temozolomide, tumor treating fields, optune, novocure, glioblastoma, brain tumor
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Treating FieldsDevice
Also called Optune, Novocure
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.
TemozolomideDrug
Also called Temodar
Patients will be given temozolomide according to routine treatment dosing and schedule.
Radiation TherapyRadiation
Patients will be given radiation therapy according to routine treatment dosing and schedule.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients will receive trimodal therapy consisting of tumor treating fields therapy with the Optune device concurrent with temozolomide and radiation therapy. Receives: Device: Tumor Treating Fields; Drug: Temozolomide; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Treatment-Related Adverse Events Associated With Trimodal Therapy
Number of patients who experienced a treatment-related adverse event
Measured: 15 Weeks (8 weeks after completion of trimodal therapy)
Severity of Treatment-Related Adverse Events Associated With Trimodal Therapy
Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)
Measured: 15 weeks (8 weeks after completion of trimodal therapy)
Secondary outcomes (2)
Overall Survival Rate
Number of patients alive at Day 106 (15 weeks), end of main study period
Measured: Day 106
Progression-free Survival at 6 Months and 24 Months
Number of patients who are progression free at 6 months and 24 months. Progression is defined as any of the following: greater than or equal to 25% increase in sum of lesions compared with smallest tumor measurement obtained, significant increase in T2/FLAIR non-enhancing lesions, any new lesion, clear clinical deterioration not attributable to other causes, or clear progression of non-measureable disease.
Measured: 6 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start2 Dec 2019
- Primary completion24 Feb 2021
- Study completion24 Feb 2022
Why it stopped: Prinicipal Investigator departure from institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study is an open-label pilot study. Following surgery, eligible patients will start tumor treating fields therapy with the Optune device less than 2 weeks prior to radiation and temozolomide given at a dose and schedule conforming to routine treatment.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, NovoCure Ltd.
- Responsible party
- Sponsor
- Investigators
- Ricky Chen, MD, Principal investigator, Providence Health and Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705351
- Sponsor's protocol ID
- UNITYGBM01
- Status last verified
- Aug 2023
- First submitted
- 8 Oct 2018
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity)
- ClinicalTrials.gov ID
- NCT03705351
- Acronym / sponsor ID
- UNITYGBM01
- Conditions
- Glioblastoma, Cancer of Brain, Glioblastoma Multiforme, Brain Tumor
- Keywords
- temozolomide, tumor treating fields, optune, novocure, glioblastoma, brain tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Prinicipal Investigator departure from institution
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- University of California, San Francisco, NovoCure Ltd.
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.
Detailed description
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.
The expected toxicity is skin related, and patients will be followed closely with weekly skin and neurological examinations during radiation therapy and for 8 weeks afterwards to capture any delayed toxicity as they begin adjuvant therapy per routine treatment. As long as study treatment is tolerated and their conditions remain stable, patients will continue the treatment for up to 24 months.
Prior to enrollment, an exploratory analysis of radiation dosimetry will be performed by phantom modeling incorporating the Optune arrays. The study incorporates three stages of recruitment to confirm the safety of combining tumor treating fields therapy with concurrent chemoradiation: a safety lead-in cohort of the first 6 patients enrolled, a second safety lead-in cohort of 9 patients, and an expansion cohort with 15 additional patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is an open-label pilot study. Following surgery, eligible patients will start tumor treating fields therapy with the Optune device less than 2 weeks prior to radiation and temozolomide given at a dose and schedule conforming to routine treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Tumor Treating Fields, Drug: Temozolomide, Radiation: Radiation TherapyPatients will receive trimodal therapy consisting of tumor treating fields therapy with the Optune device concurrent with temozolomide and radiation therapy. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- GBM or Gliosarcoma by histology
- MGMT methylation status and IDH mutation status must be assessed at the study site or patient's referral center. MGMT status will be used for stratification purposes but will not exclude patients from this study if they are either methylated, unmethylated, or indeterminate, or in process at the time of enrollment. Similarly, subjects with tumors that are IDH mutated or wild type are both eligible.
- Supratentorial location
- Maximum safe resection (including patients who can only safely be biopsied)
- 22 years of age or older
Key exclusion criteria (25 listed)
- Craniotomy or stereotactic biopsy wound dehiscence or infection
- Known by history to be HIV positive or to have an AIDS-related illness, active Hepatitis B, or active Hepatitis C (testing not required)
- Presence of skull defects (bullets, metal fragments, missing bone)
- Patients with implanted electronic medical devices (including but not limited to: pacemaker, vagal nerve stimulator, or pain stimulator)
- Prior invasive malignancy, unless disease free for 3 or more years, with the exception of basal cell carcinoma, cervical carcinoma in situ, or melanoma in situ
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 |
|---|---|---|
| Tumor Treating FieldsAlso: Optune, NovocureOptune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study. | Device | Treatment |
| TemozolomideAlso: TemodarPatients will be given temozolomide according to routine treatment dosing and schedule. | Drug | Treatment |
| Radiation TherapyPatients will be given radiation therapy according to routine treatment dosing and schedule. | Radiation | Treatment |
Primary outcome
Rate of Treatment-Related Adverse Events Associated With Trimodal Therapy
Time frame: 15 Weeks (8 weeks after completion of trimodal therapy)
Number of patients who experienced a treatment-related adverse event
Severity of Treatment-Related Adverse Events Associated With Trimodal Therapy
Time frame: 15 weeks (8 weeks after completion of trimodal therapy)
Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)
2 secondary outcomes
Overall Survival Rate
Time frame: Day 106
Progression-free Survival at 6 Months and 24 Months
Time frame: 6 months and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Providence Brain \& Spine Institute Clinical ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ricky Chen, MD principal investigator
Providence Health and Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tumor Treating Fields, Temozolomide and Radiation Therapy in people with Glioblastoma and Cancer of Brain, run by Providence Health & Services at 2 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 12 inclusion and 25 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Treatment-Related Adverse Events Associated With Trimodal Therapy (time frame: 15 Weeks (8 weeks after completion of trimodal therapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2024.