Assessing T cell behavior in glioblastoma patients
Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma
This study looks at how T cells behave in the bone marrow of glioblastoma patients to see if it can help improve future treatments for their cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04657146 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather foundational data on T cell sequestration in the bone marrow of patients with glioblastoma. The researchers will evaluate variations in blood and bone marrow T cell counts over time and in relation to treatment, as well as the levels of the sphingosine-1-phosphate receptor 1 (S1P1) on T cells. By understanding these dynamics, the study seeks to identify potential biomarkers and optimal timing for future immunotherapy interventions targeting T cell dysfunction. The ultimate goal is to inform the development of novel anti-tumor strategies based on these findings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed glioblastoma who are scheduled for surgery.
Not a fit: Patients with prior therapies or active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved immunotherapy strategies for glioblastoma patients by enhancing T cell functionality against tumors.
How similar studies have performed: While the approach of targeting T cell sequestration is novel, similar studies have shown promise in understanding T cell dynamics in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years of age. * Suspected newly-diagnosed GBM, World Health Organization (WHO) Grade IV with intent for gross total resection (as defined above). * Accessibility for treatment and follow up. * Patient consent obtained according to Duke institutional policy. * Women of child bearing potential (WOCBP) must have a negative serum pregnancy test according to standard of care prior to surgery. Exclusion Criteria: * Prior therapy (other than steroids or stereotactic biopsy) or concomitant immunotherapy. * Pregnant or breast-feeding during the study period. * Patients with an active infection, or febrile within 24 hours of surgery. * Patients with inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune disease. * Patients with history of or active hematologic or bone marrow diseases, including but not limited to diagnosed lymphomas, leukemias, sickle cell or other anemias not associated with their current condition or polycythemia vera. * Prior bone marrow harvests preceding this study. * Patients with known or suspected immunodeficiency or human immunodeficiency virus (HIV). * Hematocrit \< 24 % pre-operatively. * Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment or comply with protocol.
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Peter Fecci, M.D., Ph.D. — Duke University
- Study coordinator: Peter Fecci, M.D., Ph.D.
- Email: peter.fecci@duke.edu
- Phone: 919 681 2610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.