Status:
COMPLETED
Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
* Participants will undergo a craniotomy (brain surgery) to remove as much of the tumor as possible from their brain. A pathologist will examine the tissue to determine whether the cells are viable. I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00694330
Start Date
June 1 2008
End Date
August 1 2009
Last Update
June 22 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115