Clinical trial · Observational
Qualitative, Qualitative, and Functional Studies Over the First Year in Measuring Immune System Response During the First Year of Therapy in Patients With Brain Tumors
Determining the Competence of the Immune System Over the First Year of Therapy in Patients With Glioma: A Battery of Quantitative, Qualitative and Functional Measures of Immune Readiness
- 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 research trial studies qualitative, qualitative, and functional studies over the first year in measuring immune system response in patients with brain tumors. Measuring the number of immune cells, whether these immune cells work correctly, and response to 2 vaccines at several times during the first year of treatment may help find out how active the immune system responds to fight infection and cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Oligodendroglioma | Oligodendroglioma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hepatitis A Vaccine | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Tetanus Toxoid Vaccine | Biological | — | UNRESOLVED |
| Trivalent Influenza Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Basic Science Group II (vaccination at 9 months)
- description
- Patients undergo standard of care treatment and collection of blood samples as in Group I. Patients then receive hepatitis A and tetanus toxoid vaccinations at month 9.
- interventionNames
- Biological: Hepatitis A Vaccine
- Other: Laboratory Biomarker Analysis
- Biological: Tetanus Toxoid Vaccine
- Biological: Trivalent Influenza Vaccine
- label
- Basic Science Groups I (vaccination pre-treatment)
- description
- Patients receive standard of care hepatitis A or B vaccine, tetanus toxoid vaccine, and trivalent influenza vaccine and then undergo standard of care treatment external beam radiation therapy and receive standard of care temozolomide. Patients also undergo collection of blood Samples monthly for the first 8 months and then bimonthly for up to 12 months for analysis via flow cytometry, (CFSE) assay, live cell/dead cell distinction assay, and determination of naïve and memory immune response.
- interventionNames
- Biological: Hepatitis A Vaccine
- Other: Laboratory Biomarker Analysis
- Biological: Tetanus Toxoid Vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically or histologically diagnosed primary central nervous system astrocytoma or oligodendroglioma of World Health Organization grade II, III or IV * Anticipated to undergo treatment with concurrent chemoradiation with conformal external beam radiotherapy in combination with low-dose temozolomide (75 mg/m\^2) followed by adjuvant temozolomide (150-200 mg/m\^2) * Able to provide informed consent * Karnofsky performance status \>= 50% * Willing and able to receive the tetanus toxoid and hepatitis vaccination (though prior vaccination with either vaccine is not a contraindication to eligibility) Exclusion Criteria: * Concurrent enrollment on an experimental study involving an agent whose primary mechanism of action is the immune system (i.e. immune checkpoint inhibition, oncologic vaccine, or other immune-directed therapies); Note: patients enrolled on an experimental study or receiving another concurrent treatment in addition to standard chemoradiation whose primary mechanism of action is NOT the immune system will be eligible for enrollment * Patients unable to receive tetanus toxoid vaccination * Guillain-Barré syndrome =\< 6 weeks after previous dose of a tetanus toxoid-containing vaccine; unstable neurologic condition (e.g., cerebrovascular events and acute encephalopathic conditions) which does not include the patient's primary brain tumor; history of an Arthus reaction following a previous dose of a tetanus toxoid-containing and/or diphtheria toxoid-containing vaccine * Patients unable to receive hepatitis vaccination
References
Publications (0)
Data not yet available