We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Glioma Anaplastic Astrocytoma Anaplastic Astro-oligodendroglioma Glioblastoma Biological: autologous tumor lysate-pulsed DC vaccination Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma
Actual Study Start Date : October 8, 2010
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
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.
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.
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).
Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC



Primary Outcome Measures :
  1. Most effective combination of DC vaccine components [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Time to tumor progression and overall survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204684


Locations
United States, California
University of Los Angeles, California
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center

Publications:
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01204684     History of Changes
Other Study ID Numbers: 10-000202
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Jonsson Comprehensive Cancer Center:
dendritic cells
glioma
vaccine
glioma of WHO Grade III or IV

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vaccines
Poly ICLC
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers