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Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors
This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, November 2007
Sponsored by: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00576537
  Purpose

This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.


Condition Intervention Phase
Glioblastoma
Biological: Dendritic Cell Immunotherapy
Biological: Dendritic Cell Vaccine
Phase II

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System

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

Primary Outcome Measures:
  • Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2001
Estimated Study Completion Date: October 2008
Arms Assigned Interventions
1: Experimental Biological: Dendritic Cell Immunotherapy
Patients will receive four vaccines.
Biological: Dendritic Cell Vaccine
Four vaccines
Biological: Dendritic Cell Vaccine
Four vaccines will be given to patients

Detailed Description:

To become eligible for therapy the following criteria must be fulfilled:

  • No age or gender limit
  • Patients with atypical malignant brain tumors.
  • Must have a Karnofsky performance of at least 60%
  • Hematologic studies and chemistry profiles will be within the parameters of the protocol
  • Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine.
  • Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.
  Eligibility

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

Inclusion Criteria:

  • No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.
  • Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
  • patients with atypical malignant brain tumor will be eligible.
  • Patients must have a Karnofsky performance score of at least 60%
  • patients may be maintained on glucocorticoid therapy at the lowest possible dose.
  • Baseline hematologic studies and chemistry profiles must meet the criteria.
  • Tumor specimen of adequate size to yield protein concentration in sufficient quantity.
  • Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination.
  • Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
  • Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology.
  • Patient must be capable of signing IRB approved Research Consent and Release of medical Records form.

Exclusion Criteria:

  • Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
  • The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
  • Patients with a known history of an autoimmune disorder.
  • Inability to give informed consent.
  • Pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576537

Contacts
Contact: Marites O. Francisco, RN 310 423 0022 Marites.Francisco@cshs.org

Locations
United States, California
Cedars Sinai Medical center Recruiting
8700 Beverly Blvd., California, United States, 90048
Contact: Marites O Francisco, RN     310-423-0022     Marites.Francisco@cshs.org    
Cedars Sinai Medical Center Recruiting
8700 Beverly Blvd., California, United States, 90048
Contact: Marites O. Francisco, RN     310-423-0022     Marites.Francisco@cshs.org    
Principal Investigator: John Yu, M.D.            
Principal Investigator: John Yu, M.D.            
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: John Yu, M.D. Cedars-Sinai Medical Center
  More Information

Responsible Party: Cedars Sinai Medical Center ( John Yu, M.D. )
Study ID Numbers: 3368
Study First Received: December 18, 2007
Last Updated: January 2, 2008
ClinicalTrials.gov Identifier: NCT00576537  
Health Authority: United States: Food and Drug Administration

Keywords provided by Cedars-Sinai Medical Center:
New/Recurrent Glioblastoma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009