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

Sponsors and Collaborators:	Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00694330

Purpose

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.

Condition	Intervention	Phase
Glioma	Biological: GM-K562 Vaccination	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Lethally irradiated autologous glioma cells combined with GM-K562 cells as vaccine therapy given once a week for three weeks then every other week.

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. 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694330

Contacts

Contact: William Curry, MD

617-726-3779

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: William Curry, MD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Patrick Wen, MD

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

William Curry, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( William Curry, MD )
Study ID Numbers:	06-349
Study First Received:	June 6, 2008
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00694330 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

vaccine
GM-K562
malignant glioma

Study placed in the following topic categories:

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009