Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
Completed · Phase 1
Conditions studied: Glioma
In brief
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.
Key facts
- Study ID
- NCT00694330
- Run by
- Massachusetts General Hospital
- People needed
- 11
- Starts
- 2008-06-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2017-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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