Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Yu, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00576537
First received: December 18, 2007
Last updated: February 18, 2013
Last verified: February 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 50
Study Start Date: March 2001
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Dendritic Cell Immunotherapy
Patients will receive four vaccines.
Other Name: Dendritic Cell vaccine
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
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: NCT00576537

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

No publications provided

Responsible Party: John Yu, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00576537     History of Changes
Other Study ID Numbers: 3368
Study First Received: December 18, 2007
Last Updated: February 18, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Glioblastoma
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014