Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients

Glioblastoma Clinical Trial

— PROPHETIC  

Official title:

Predicting Response Patterns to Treatment in Glioblastoma (GBM) Oncology Patients Based on Host Response Evaluation During Anti-cancer Treatments

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04219475
• Other study ID #: OH-GBMHR
• Status: Suspended
• Start date: January 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2022
• Source: OncoHost Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PROPHETIC GBM - Predicting response patterns to treatment in Glioblastoma (GBM) oncology patients based on host response evaluation during anti-cancer treatments

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of informed consent prior to any study-specific procedures.

2. Male or female aged at least 18 years.

3. KPS not less than 50.

4. Normal hematologic, renal and liver function:

1. Absolute neutrophil count above 1500/mm3, platelets above 100,000/mm3, hemoglobin above 9 g/dL;

2. Creatinine concentration not more than 1.4 mg/dL, or creatinine clearance above 40 mL/min;

3. Total bilirubin below 1.5 mg/dL, ALT+ AST levels not more than 3 times above the upper normal limit.

5. Patients planned to receive standard of care TMZ+RT treatment; TTF therapy during RT is permitted.

Exclusion Criteria:

1. 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.

2. Participation in another clinical trial which includes an investigational drug.

3. Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.

4. Pregnancy.

Related Conditions & MeSH terms

• Glioblastoma

Locations

Country	Name	City	State
Israel	Rambam medical center	Haifa
Israel	Rabin medical center	Petah tikva
Israel	Sourasky medical center	Tel Aviv
Israel	Sheba medical center	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
OncoHost Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Shaked 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. Review. — View Citation

Shaked 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment	complete remission (CR); partial remission (PR), stable disease (SD), progressive disease (PD), suspected pseudo-progression, as defined by RANO	One month after completion of TMZ + RT
Primary	Response to treatment	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO	3 months after treatment completion in the first year
Primary	Response to treatment	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO	6 months after treatment completion in the first year
Primary	Response to treatment	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO	9 months after treatment completion in the first year
Primary	Response to treatment	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO	12 months after treatment completion in the first year
Primary	Response to treatment	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO	18 months after treatment completion in the first year
Primary	Response to treatment	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO	24 months after treatment completion in the first year
Primary	Response to treatment	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO	30 months after treatment completion in the first year
Primary	Response to treatment	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO	36 months after treatment completion in the first year
Primary	Blood levels of proteins	Blood levels of proteins representing the Host response at baseline	Pre-chemoradiation therapy - 7 days or less before the first administration
Primary	Blood levels of proteins	Changes in Blood levels of proteins representing the Host response compared to baseline	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
Primary	Blood levels of proteins	Changes in Blood levels of proteins representing the Host response compared to baseline	21+/-2 days after the first TMZ dose
Primary	Blood levels of proteins	Changes in Blood levels of proteins representing the Host response compared to baseline	At first detection of progressive disease (PD) based on MRI evaluation during follow-up assessed up to 36 months
Primary	Blood levels of proteins	Changes in Blood levels of proteins representing the Host response compared to baseline	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	OS	Overall survival	Until death or 3 years
Secondary	PFS	Progression free survival	up to 3 years