GlioblastomaPROPHETICNCT04219475
Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients
An observational study of Glioblastoma, run by OncoHost Ltd. at 4 sites in Israel.
Trial summary
PROPHETIC GBM - Predicting response patterns to treatment in Glioblastoma (GBM) oncology patients based on host response evaluation during anti-cancer treatments Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 1,000 participants
- Where
- 4 sitesIsrael
- Study dates
- Jan 2023to Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients recruited for the study except for 1. Patients who discontinued the TMZ during the first 2 weeks of treatment, unless the drug was stopped due to tumor progression. 2. Patients who didn't receive at least 46 Gy in the 6 weeks regimen or 30 Gy in the 3 weeks regimen, unless the treatment was stopped due to grade 3 and higher toxicity. 3. Patients who chose to discontinue the treatment for reasons other than disease progression or serious side effects unless the treatment was stopped due to grade 3 and highertoxicity.
Who may be able to join
- Provision of informed consent prior to any study-specific procedures.
- Male or female aged at least 18 years.
- KPS not less than 50.
- Normal hematologic, renal and liver function:
- Absolute neutrophil count above 1500/mm3, platelets above 100,000/mm3, hemoglobin above 9 g/dL;
- Creatinine concentration not more than 1.4 mg/dL, or creatinine clearance above 40 mL/min;
- Total bilirubin below 1.5 mg/dL, ALT+ AST levels not more than 3 times above the upper normal limit.
- Patients planned to receive standard of care TMZ+RT treatment; TTF therapy during RT is permitted.
Who cannot join
- Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of surgery. Except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to screening, and carcinoma in situ of the cervix that have been completely excised and cured at least 5 years prior to screening.
- Participation in another clinical trial which includes an investigational drug.
- Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
- Pregnancy.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Rambam medical center
Haifa
Rabin medical center
Petah Tikva
Sourasky medical center
Tel Aviv
Sheba medical center
Tel HaShomer
About this study
Official title: Predicting Response Patterns to Treatment in Glioblastoma (GBM) Oncology Patients Based on Host Response Evaluation During Anti-cancer Treatments
PROPHETIC GBM - Predicting response patterns to treatment in Glioblastoma (GBM) oncology patients based on host response evaluation during anti-cancer treatments
Read the detailed description
The goal of this research study is identify new host response proteins, pathways and mechanisms that are associated with responsiveness to GBM treatment modalities.
This will serve as a tool for physicians when making treatment decisions. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide up to 5 blood samples and clinical data will be collected from their medical records.
The data obtained from the blood samples and the medical records of the patients will be used to search for potential mechanisms that are involved in response to treatment, and to identify potential targets to increase the response, and hence, increase treatment effectiveness or suggest potential new treatments.
- Conditions
- Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GBM patients | Newly diagnosed patients above 18 years of age with GBM receiving standard of care, i.e., maximal surgical resection possible followed by radiation therapy (RT) plus temozolomide (TMZ) therapy and maintenance TMZ. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
complete remission (CR); partial remission (PR), stable disease (SD), progressive disease (PD), suspected pseudo-progression, as defined by RANO
Measured: One month after completion of TMZ + RT
Response to treatment
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Measured: 3 months after treatment completion in the first year
Response to treatment
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Measured: 6 months after treatment completion in the first year
Response to treatment
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Measured: 9 months after treatment completion in the first year
Response to treatment
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Measured: 12 months after treatment completion in the first year
Response to treatment
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Measured: 18 months after treatment completion in the first year
Response to treatment
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Measured: 24 months after treatment completion in the first year
Response to treatment
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Measured: 30 months after treatment completion in the first year
Response to treatment
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Measured: 36 months after treatment completion in the first year
Blood levels of proteins
Blood levels of proteins representing the Host response at baseline
Measured: Pre-chemoradiation therapy - 7 days or less before the first administration
Blood levels of proteins
Changes in Blood levels of proteins representing the Host response compared to baseline
Measured: After the first chemoradiation administration - at least 24 h after the first temozolomide (TMZ) dose, and between 24-48 h after the first radiation therapy (RT) dose
Blood levels of proteins
Changes in Blood levels of proteins representing the Host response compared to baseline
Measured: 21+/-2 days after the first TMZ dose
Blood levels of proteins
Changes in Blood levels of proteins representing the Host response compared to baseline
Measured: At first detection of progressive disease (PD) based on MRI evaluation during follow-up assessed up to 36 months
Blood levels of proteins
Changes in Blood levels of proteins representing the Host response compared to baseline
Measured: If the previous detection of progression turned out to be pseudo-progression, then an additional blood sample should be drawn at time of progression, assessed up to 36 months
Secondary outcomes (2)
OS
Overall survival
Measured: Until death or 3 years
PFS
Progression free survival
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study startJan 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Priority changes of the company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoHost Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dror Limon, MD, Principal investigator, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219475
- Sponsor's protocol ID
- OH-GBMHR
- Acronym
- PROPHETIC
- Status last verified
- Apr 2022
- First submitted
- 31 Dec 2019
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shaked Y. Balancing efficacy of and host immune responses to cancer therapy: the yin and yang effects. Nat Rev Clin Oncol. 2016 Oct;13(10):611-26. doi: 10.1038/nrclinonc.2016.57. Epub 2016 Apr 26.
PubMed 27118493Shaked Y, Kerbel RS. Antiangiogenic strategies on defense: on the possibility of blocking rebounds by the tumor vasculature after chemotherapy. Cancer Res. 2007 Aug 1;67(15):7055-8. doi: 10.1158/0008-5472.CAN-07-0905.
PubMed 17671170Shaked Y, Bocci G, Munoz R, Man S, Ebos JM, Hicklin DJ, Bertolini F, D'Amato R, Kerbel RS. Cellular and molecular surrogate markers to monitor targeted and non-targeted antiangiogenic drug activity and determine optimal biologic dose. Curr Cancer Drug Targets. 2005 Nov;5(7):551-9. doi: 10.2174/156800905774574020.
PubMed 16305351
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Response Patterns to Treatment in Glioblastoma (GBM) Oncology Patients Based on Host Response Evaluation During Anti-cancer Treatments
- ClinicalTrials.gov ID
- NCT04219475
- Acronym / sponsor ID
- PROPHETIC / OH-GBMHR
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Priority changes of the company
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- OncoHost Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Jan 2020 (actual)
- 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.
PROPHETIC GBM - Predicting response patterns to treatment in Glioblastoma (GBM) oncology patients based on host response evaluation during anti-cancer treatments
Detailed description
The goal of this research study is identify new host response proteins, pathways and mechanisms that are associated with responsiveness to GBM treatment modalities.
This will serve as a tool for physicians when making treatment decisions. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide up to 5 blood samples and clinical data will be collected from their medical records.
The data obtained from the blood samples and the medical records of the patients will be used to search for potential mechanisms that are involved in response to treatment, and to identify potential targets to increase the response, and hence, increase treatment effectiveness or suggest potential new treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBM patients | – | –Newly diagnosed patients above 18 years of age with GBM receiving standard of care, i.e., maximal surgical resection possible followed by radiation therapy (RT) plus temozolomide (TMZ) therapy and maintenance TMZ. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients recruited for the study except for 1. Patients who discontinued the TMZ during the first 2 weeks of treatment, unless the drug was stopped due to tumor progression. 2. Patients who didn't receive at least 46 Gy in the 6 weeks regimen or 30 Gy in the 3 weeks regimen, unless the treatment was stopped due to grade 3 and higher toxicity. 3. Patients who chose to discontinue the treatment for reasons other than disease progression or serious side effects unless the treatment was stopped due to grade 3 and highertoxicity.
Key inclusion criteria (8 listed)
- Provision of informed consent prior to any study-specific procedures.
- Male or female aged at least 18 years.
- KPS not less than 50.
- Normal hematologic, renal and liver function:
- Patients planned to receive standard of care TMZ+RT treatment; TTF therapy during RT is permitted.
Key exclusion criteria (4 listed)
- Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of surgery. Except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to screening, and carcinoma in situ of the cervix that have been completely excised and cured at least 5 years prior to screening.
- Participation in another clinical trial which includes an investigational drug.
- Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response to treatment
Time frame: One month after completion of TMZ + RT
complete remission (CR); partial remission (PR), stable disease (SD), progressive disease (PD), suspected pseudo-progression, as defined by RANO
Response to treatment
Time frame: 3 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Response to treatment
Time frame: 6 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Response to treatment
Time frame: 9 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Response to treatment
Time frame: 12 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Response to treatment
Time frame: 18 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Response to treatment
Time frame: 24 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Response to treatment
Time frame: 30 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Response to treatment
Time frame: 36 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Blood levels of proteins
Time frame: Pre-chemoradiation therapy - 7 days or less before the first administration
Blood levels of proteins representing the Host response at baseline
Blood levels of proteins
Time frame: After the first chemoradiation administration - at least 24 h after the first temozolomide (TMZ) dose, and between 24-48 h after the first radiation therapy (RT) dose
Changes in Blood levels of proteins representing the Host response compared to baseline
Blood levels of proteins
Time frame: 21+/-2 days after the first TMZ dose
Changes in Blood levels of proteins representing the Host response compared to baseline
Blood levels of proteins
Time frame: At first detection of progressive disease (PD) based on MRI evaluation during follow-up assessed up to 36 months
Changes in Blood levels of proteins representing the Host response compared to baseline
Blood levels of proteins
Time frame: If the previous detection of progression turned out to be pseudo-progression, then an additional blood sample should be drawn at time of progression, assessed up to 36 months
Changes in Blood levels of proteins representing the Host response compared to baseline
2 secondary outcomes
OS
Time frame: Until death or 3 years
PFS
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 27118493Shaked Y. Balancing efficacy of and host immune responses to cancer therapy: the yin and yang effects. Nat Rev Clin Oncol. 2016 Oct;13(10):611-26. doi: 10.1038/nrclinonc.2016.57. Epub 2016 Apr 26.
- Background: PubMed 17671170Shaked Y, Kerbel RS. Antiangiogenic strategies on defense: on the possibility of blocking rebounds by the tumor vasculature after chemotherapy. Cancer Res. 2007 Aug 1;67(15):7055-8. doi: 10.1158/0008-5472.CAN-07-0905.
- Background: PubMed 16305351Shaked Y, Bocci G, Munoz R, Man S, Ebos JM, Hicklin DJ, Bertolini F, D'Amato R, Kerbel RS. Cellular and molecular surrogate markers to monitor targeted and non-targeted antiangiogenic drug activity and determine optimal biologic dose. Curr Cancer Drug Targets. 2005 Nov;5(7):551-9. doi: 10.2174/156800905774574020.
- 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.
Dror Limon, MD principal investigator
Sourasky Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by OncoHost Ltd. at 4 sites in Israel.
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 8 inclusion and 4 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: paused, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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.
Are results available for this study?
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?
Response to treatment (time frame: One month after completion of TMZ + RT). The study lists 14 primary outcomes in all. 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 NCT04219475, which also lists 3 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 19 Apr 2022.