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Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04219475
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 OncoHost Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Dror Limon, MD
Principal Investigator Affiliation Sourasky Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Suspended
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rambam medical center, Haifa, Israel

Status

Address

Rambam medical center

Haifa, ,

Rabin medical center, Petah tikva, Israel

Status

Address

Rabin medical center

Petah tikva, ,

Sourasky medical center, Tel Aviv, Israel

Status

Address

Sourasky medical center

Tel Aviv, ,

Sheba medical center, Tel HaShomer, Israel

Status

Address

Sheba medical center

Tel HaShomer, ,

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