Clinical trial · Observational
Molecular Profiling in Guiding Individualized Treatment Plan in Adults With Recurrent/Progressive Glioblastoma
A Pilot Trial Testing the Feasibility of Using Molecular Profiling to Guide an Individualized Treatment Plan in Adults With Recurrent/Progressive Glioblastoma
NCT02060890CI-TRIAL-00072163TGENcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This current study will use a new treatment approach based on each patient's tumor genomic profiling consisting of whole genome sequencing, exome analysis, and RNA sequencing as well as predictive modeling. This new treatment strategy has shown promising results in adult patients with other solid tumors.
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 |
|---|---|---|---|
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| specialized tumor board recommendation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group A
- description
- Patients will undergo collection of tumor at the time of tumor resection and after confirmation of tumor progression and will have blood samples drawn pre-surgery and during standard of care follow-up visits. Patients will then be provided with a specialized tumor board recommendations for personalized treatment options for up to 4 medications based on the specimen analysis results within 35 days of surgery. Patients may then elect to initiate recommended therapy within 42 days of surgery.
- interventionNames
- Other: specialized tumor board recommendation
Primary outcomes (1)
- measure
- Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery
- timeFrame
- 35 days from surgery to making genomic informed treatment recommendation
- description
- To demonstrate feasibility, we would want the treatment recommendation to be fully complete within 35 calendar days in at least 85% of patients for which sufficient RNA and DNA is available.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures * Have a life expectancy of at least 3 months * Patients must have a diagnosis of histologically confirmed Glioblastoma that is felt on imaging to be progressive despite standard of care treatment * at least 18 years of age * Patient is a good medical candidate for a standard of care surgical procedure * Patients may enroll independent of number of prior therapies, but must have received prior radiation therapy * Patients must have a performance status (KPS) of at least 60. Exclusion Criteria: * Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent Eligibility for treatment using the specialized Tumor Board recommendations * Patients must have fully recovered from any toxicity associated with surgery * Must begin treatment no longer than 35 calendar days from surgery * Must have KPS at least 60 * Must have Absolute Neutrophil Count (ANC) at least 1500/mm3, platelets at least 125,000/mm2, Hg at least 8 gm/dl * Must have electrolytes (Na, K, Co2, Cl) within normal limits using institutional guidelines * Must have baseline MRI within 14 days prior to starting cycle 1, day 1 of treatment (+/- 3 days) * Additional laboratory guidelines will be based upon therapies suggested by the specialized Tumor Board based upon anticipated, known toxicities of those agents and must be within at least 1.5 x upper normal limits of institutional normal limits * Patient must agree to follow the recommended treatment regimen, including clinic visits, laboratory, imaging, and toxicity assessments
References
Publications (0)
Data not yet available
No reference posted for this study.