Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients

NCT04219475 | Suspended

• 1 other identifier: OH-GBMHR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (14)

• 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

• Response to treatment

  CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO

  3 months after treatment completion in the first year

• Response to treatment

  CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO

  6 months after treatment completion in the first year

• Response to treatment

  CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO

  9 months after treatment completion in the first year

• Response to treatment

  CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO

  12 months after treatment completion in the first year

• Response to treatment

  CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO

  18 months after treatment completion in the first year

• Response to treatment

  CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO

  24 months after treatment completion in the first year

• Response to treatment

  CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO

  30 months after treatment completion in the first year

• Response to treatment

  CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO

  36 months after treatment completion in the first year

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• OS

  Until death or 3 years

• PFS

  up to 3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OncoHost Ltd.: lead

Study Sites (4)

Rambam medical center

Haifa, Israel

Location

Rabin medical center

Petah Tikva, Israel

Location

Sourasky medical center

Tel Aviv, Israel

Location

Sheba medical center

Tel Litwinsky, Israel

Location

Related Publications (3)

• 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.

  PMID: 27118493 BACKGROUND

• 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. doi: 10.1158/0008-5472.CAN-07-0905.

  PMID: 17671170 BACKGROUND

• 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. doi: 10.2174/156800905774574020.

  PMID: 16305351 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Dror Limon, MD

  Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 7, 2020
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

IL (4)