A Phase I Study of Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
- 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. If not, we will not be able to make the vaccine and the
participant will not be eligible to proceed with this treatment protocol.
- The dose of the vaccine will be determined by the number of tumor cells that we are
able to collect from the surgery. We will also be trying to determine the appropriate
number of GM-K562 cells that can be given safely. We will do this by assigning groups
of participants to different dose levels of GM-K562.
- For the first three weeks of this study, vaccines will be given once each week. After
the first three weeks, vaccines will be given every other week.
- Before the first and after the fourth vaccinations, a small amount of the participants
own irradiated tumor cells will be injected under their skin to see if their immune
system will react against it. If the participant develops a rash, they may be asked to
undergo a small skin biopsy for additional evaluation. These biopsies are optional.
- During the course of the study, we will also be collecting blood samples to evaluate
the effect that the vaccinations may have on the immune system. These tests will be
done every month.
- Participants will have an MRI once every two months.
- The following tests and procedures will be done before the participant receive the
vaccine and every two weeks (During the first month, these will be performed on Days 1,
3 or 4, 15, 29 and 31 or 32): medical history; physical exam; vital signs; neurological
exam; routine blood tests; research blood tests.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
William Curry, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|