Clinical trial · Interventional
Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
A Phase I Study of Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
- 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 study is testing the safety of a vaccination of cells called GM-K562 cells mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating an immune response to cancer. This newly developed vaccine may stop cancer cells from growing.
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 |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-K562 Vaccination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GM-K562 Vaccination
- interventionNames
- Biological: GM-K562 Vaccination
Primary outcomes (2)
- measure
- To determine the feasibility of preparing lethally irradiated autologous glioma cells for use in combination with irradiated GM-K562 cells as vaccination therapy in this patient population.
- timeFrame
- 3 years
- measure
- To determine the safety and biological activity of subcutaneous and intradermal injection of irradiated autologous malignant glioma cells mixed with irradiated GM-CSF producing GM-K562 cells in this patient population.
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have recurrent malignant glioma, having already been diagnosed with and treated for biopsy-proven glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma or gliosarcoma. * Patients will already have been treated with external beam irradiation with or without chemotherapy. * Patients must be able to undergo a MRI. * A priori clinical indication for open resection/debulking of recurrent malignant glioma. * At the time of vaccination, patients must be at least 4 weeks from completion of radiotherapy and 4 weeks from cytotoxic chemotherapy. * Serum absolute neutrophil count greater than or equal to 1500/mm3 * Serum platelets greater than or equal to 50,000/mm3 * Serum sodium greater than or equal to 125 mmol/L * 18 years of age or older * Karnofsky Performance Score of 60% or greater Exclusion Criteria: * Uncontrolled active infection * Pregnancy or nursing mothers * HIV infection * Evidence of active infection with Hepatitis B or C * Concurrent malignancy * Active or clinically relevant autoimmune disease * Urgent need for surgical decompression (at the time of initial consultation) * Previous participation in a gene therapy or immunotherapy trial * Inability to provide informed consent because of altered mental status or mental illness * Any other medical, surgical or psychiatric condition which could interfere with the patient's inability to comply with protocol regimen
References
Publications (0)
Data not yet available