Clinical trial · Observational
Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients
Predicting Response Patterns to Treatment in Glioblastoma (GBM) Oncology Patients Based on Host Response Evaluation During Anti-cancer Treatments
NCT04219475CI-TRIAL-00057895PROPHETICsuspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Priority changes of the company
Summary
Brief summary (as posted)
PROPHETIC GBM - Predicting response patterns to treatment in Glioblastoma (GBM) oncology patients based on host response evaluation during anti-cancer treatments
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- GBM patients
- description
- 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.
Primary outcomes (14)
- measure
- Response to treatment
- timeFrame
- One month after completion of TMZ + RT
- description
- complete remission (CR); partial remission (PR), stable disease (SD), progressive disease (PD), suspected pseudo-progression, as defined by RANO
- measure
- Response to treatment
- timeFrame
- 3 months after treatment completion in the first year
- description
- CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
- measure
- Response to treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDShaked 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
- BACKGROUNDShaked 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
- BACKGROUNDShaked 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