Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
|ClinicalTrials.gov Identifier: NCT00694330|
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Biological: GM-K562 Vaccination||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor|
|Actual Study Start Date :||June 2008|
|Primary Completion Date :||August 2009|
|Study Completion Date :||August 2009|
|Experimental: GM-K562 Vaccination||
Biological: GM-K562 Vaccination
Lethally irradiated autologous glioma cells combined with GM-K562 cells as vaccine therapy given once a week for three weeks then every other week.
- 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. [ Time Frame: 3 years ]
- 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. [ Time Frame: 3 years ]
- Progression free survival [ Time Frame: 3 years ]
- overall survival [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694330
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||William Curry, MD||Massachusetts General Hospital|