Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Surasak Phuphanich, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00576641
First received: December 18, 2007
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

The purpose of the Dendritic Cell Immunotherapy study for patients with glioblastoma and/or brainstem glioma is to determine whether in patients with malignant brain tumors, dendritic cells injected peripherally can reactivate the immune system against the brain tumor.


Condition Intervention Phase
Brain Stem Glioma
Glioblastoma
Biological: Dendritic cell Vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase l Trial of Tumor Associated Antigen Pulsed Dendritic Cell Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Evaluate safety/toxicity of Dendritic cell vaccine, Monitor survival and time to progression and monitor the cellular immune responses. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: May 2007
Study Completion Date: April 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Dendritic cell Vaccine
    Patients will receive three vaccines every two weeks
Detailed Description:

Patients will have their white blood cells removed and grown in culture under conditions to make dendritic cells. Dendritic cells are a small group of cells that belong to the white blood cell population. These cells are responsible for letting the immune system know that something foreign, like bacteria or a tumor, is in the body. Dendritic cells help the body ward off disease by alerting the immune system. In previous clinical trials, brain tumor cells called astrocytoma tumor cells and glioblastoma tumor cells were taken from the tumor that was removed during surgery. The brain tumor cells were then placed into a solution in the laboratory that made them grow. Certain parts of the brain tumor's proteins (peptides) were removed from the growing tumor cells and mixed together with the dendritic cells in the blood taken from a vein. This combination of dendritic cells and brain tumor peptides were injected into the patient's skin, like a vaccination. This process is similar to that used in vaccinations. The patients were given three and four injections of dendritic cells mixed with the tumor peptides over the course of a twenty-eight day period.

In this study, the proteins that are manufactured and known to be associated with brain cancers will be mixed with the dendritic cells obtained during leukopheresis (a procedure in which the dendritic cells are separated from the patients' blood). They will then undergo three vaccinations along with follow up clinic visits (which include evaluations and laboratory tests) to check their status.

The investigators learned that it was possible to generate an immune response in a subset of patients with malignant glioma. In addition, these cells were able to reach the brain and kill brain tumor cells. The survival of patients in this study was prolonged when compared to historical controls. Based on clinical data in subjects with brain tumors, the investigators believe that peripheral injection of dendritic cells will generate a more potent immune response for patients with brain stem gliomas and/or glioblastomas. The investigators hope to determine whether this therapy will translate into a longer survival and better quality of life in these patients in whom survival is measured in months. Through this study the investigators hope to learn more about the role of the body's immune response against cancer and about the use of dendritic cells for immunotherapy. This information may prove useful in the therapy of patients with glioblastoma and/or brainstem gliomas.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be HLA -A1 or HLA - A2 positive
  • Both male and female of child bearing age must use medically accepted form of birth control
  • Confirmed brain stem glioma and glioblastoma with MRI
  • Presence of at least one of the antigens by immunohistochemistry
  • Karnofsky performance of at least 60%
  • On maintenance glucocorticoid therapy at no more 2 mg BID
  • Hematologic and chemistry profiles within the parameters of the protocol
  • Wash ou periods from previous therapies: 6 weeks from nitrosurea, 4 weeks from chemotherapy, 2 weeks after resolution of Grade 3 or 4 toxicity
  • Able to sign IRB approved Informed consent
  • Three adults will be treated prior to any study agent administration to subjects younger than 18 years of age
  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: NCT00576641

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Surasak Phuphanich, M.D. Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Surasak Phuphanich, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00576641     History of Changes
Other Study ID Numbers: 6657
Study First Received: December 18, 2007
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
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 19, 2014