cropped color_logo_with_background.png

Clinical Trial Finder

Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00576537
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Cedars-Sinai Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 John Yu, M.D.
Principal Investigator Affiliation Cedars-Sinai Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Dendritic Cell Immunotherapy

Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells.

Interventions

Biological: - Dendritic Cell Immunotherapy

Patients will receive four vaccines.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars Sinai Medical center, Los Angeles, California

Status

Address

Cedars Sinai Medical center

Los Angeles, California, 90048

Powered By