Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients

Suspended

• Conditions: Glioblastoma

• Registration Number: NCT04219475
• Lead Sponsor: OncoHost Ltd.

Brief Summary

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 Timeline

• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-19
• Study Start: 2023-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment	36 months after treatment completion in the first year	CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Blood levels of proteins	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

Secondary Outcome Measures

Name	Time	Method
OS	Until death or 3 years	Overall survival
PFS	up to 3 years	Progression free survival

Trial Locations

Locations (4)

Rambam medical center; 🇮🇱 Haifa, Israel

Rabin medical center; 🇮🇱 Petah tikva, Israel

Sourasky medical center; 🇮🇱 Tel Aviv, Israel

Sheba medical center; 🇮🇱 Tel HaShomer, Israel