Dendritic Cell Vaccine for Patients With Brain Tumors

This study is currently recruiting participants.
Verified August 2013 by Jonsson Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01204684
First received: September 16, 2010
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Most effective combination of DC vaccine components [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to tumor progression and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204684

Locations
United States, California
University of Los Angeles, California Recruiting
Los Angeles, California, United States, 90095
Contact: Emma Young, R.N.    310-267-2621    elyoung@mednet.ucla.edu   
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01204684     History of Changes
Other Study ID Numbers: 10-000202
Study First Received: September 16, 2010
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 16, 2014