Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor

Glioma Clinical Trial

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

Status Completed

Clinical Trial 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 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.

Clinical Trial 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. 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. ;

Related Conditions & MeSH terms

• Glioma

• NCT number: NCT00694330
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 1
• Start date: June 2008
• Completion date: August 2009