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Dendritic Cell Vaccine for Patients With Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01204684
Recruitment Status : Active, not recruiting
First Posted : September 17, 2010
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE September 16, 2010
First Posted Date  ICMJE September 17, 2010
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE October 8, 2010
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
Most effective combination of DC vaccine components [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
Time to tumor progression and overall survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dendritic Cell Vaccine for Patients With Brain Tumors
Official Title  ICMJE A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma
Brief Summary The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an indication of extended survival in several patients. However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together. Dendritic cells (DC) (cells which "present" or "show" cell identifiers to the immune system) isolated from the subject's own blood will be treated with tumor-cell lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed DCs will then be injected back into the patient intradermally as a vaccine. The investigators will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some treatment cohorts. It is thought that the host immune system might be taught to "recognize" the malignant brain tumor cells as "foreign" to the body by effectively presenting unique tumor antigens to the host immune cells (T-cells) in vivo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioma
  • Anaplastic Astrocytoma
  • Anaplastic Astro-oligodendroglioma
  • Glioblastoma
Intervention  ICMJE
  • Biological: autologous tumor lysate-pulsed DC vaccination
  • Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod
  • Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC
Study Arms  ICMJE
  • Experimental: Tumor Lysate-pulsed DC vaccination
    Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.
    Intervention: Biological: autologous tumor lysate-pulsed DC vaccination
  • Experimental: Tumor lysate-pulsed DC vaccination+0.2% resiquimod.
    Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.
    Intervention: Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod
  • Experimental: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.
    Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).
    Intervention: Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2013)
60
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

PATIENT ELIGIBILITY

Inclusion Criteria

  1. Patients with newly diagnosed or recurrent glioma of WHO Grade III or IV {anaplastic astrocytoma (AA), anaplastic astro-oligodendroglioma (AO), or glioblastoma (GBM)} will be eligible for this protocol.
  2. Patients must have had surgical resection at UCLA (University of California, Los Angeles), for which a separate informed consent was signed for the collection of their tumor prior to surgery.
  3. After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
  4. Patients must be 18 years or older and able to read and understand the informed consent document. Patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
  5. Patients must have a Karnofsky performance status (KPS) rating of > 60 prior to initiating treatment. Patients may be enrolled at a KPS of < 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of > 60 by the initiation of treatment.

Exclusion Criteria

  1. Subjects with an active infection.
  2. Inability to obtain informed consent because of psychiatric or complicating medical problems.
  3. Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator.
  4. Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception.
  5. History of immunodeficiency (e.g., HIV) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy.
  6. Subjects with organ allografts.
  7. Inability or unwillingness to return for required visits and follow-up exams.
  8. Subjects who have an uncontrolled systemic malignancy that is not in remission.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01204684
Other Study ID Numbers  ICMJE 10-000202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jonsson Comprehensive Cancer Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP