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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00694330
First received: June 6, 2008
Last updated: May 3, 2010
Last verified: May 2010
  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 1

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


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 Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: William Curry, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00694330     History of Changes
Other Study ID Numbers: 06-349
Study First Received: June 6, 2008
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
vaccine
GM-K562
malignant glioma

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 28, 2014