Know Cancer

forgot password

A Phase I Study of Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor

Phase 1
18 Years
Open (Enrolling)

Thank you

Trial Information

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.

Inclusion Criteria:

- 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

- 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 Criteria:

- 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

- Any other medical, surgical or psychiatric condition which could interfere with the
patient's inability to comply with protocol regimen

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

William Curry, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

June 2011

Related Keywords:

  • Glioma
  • vaccine
  • GM-K562
  • malignant glioma
  • Glioma



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617