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Dendritic Cell Vaccine for Patients With Brain Tumors

Primary Purpose

Glioma, Anaplastic Astrocytoma, Anaplastic Astro-oligodendroglioma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

autologous tumor lysate-pulsed DC vaccination

Tumor lysate-pulsed DC vaccination+0.2% resiquimod

Tumor-lysate pulsed DC vaccination +adjuvant polyICLC

About this trial

This is an interventional treatment trial for Glioma focused on measuring dendritic cells, glioma, vaccine, glioma of WHO Grade III or IV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PATIENT ELIGIBILITY

Inclusion Criteria

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.
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.
After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
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.
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

Subjects with an active infection.
Inability to obtain informed consent because of psychiatric or complicating medical problems.
Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator.
Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception.
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.
Subjects with organ allografts.
Inability or unwillingness to return for required visits and follow-up exams.
Subjects who have an uncontrolled systemic malignancy that is not in remission.

Sites / Locations

University of Los Angeles, California

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Tumor Lysate-pulsed DC vaccination

Tumor lysate-pulsed DC vaccination+0.2% resiquimod.

Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.

Arm Description

Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.

Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.

Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).

Outcomes

Primary Outcome Measures

Most effective combination of DC vaccine components

Secondary Outcome Measures

Time to tumor progression and overall survival

Full Information

NCT ID

NCT01204684

First Posted

September 16, 2010

Last Updated

July 21, 2023

Sponsor

Jonsson Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01204684

Brief Title

Dendritic Cell Vaccine for Patients With Brain Tumors

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 8, 2010 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Anaplastic Astrocytoma, Anaplastic Astro-oligodendroglioma, Glioblastoma

Keywords

dendritic cells, glioma, vaccine, glioma of WHO Grade III or IV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tumor Lysate-pulsed DC vaccination

Arm Type

Experimental

Arm Description

Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.

Arm Title

Tumor lysate-pulsed DC vaccination+0.2% resiquimod.

Arm Type

Experimental

Arm Description

Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.

Arm Title

Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.

Arm Type

Experimental

Arm Description

Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).

Intervention Type

Biological

Intervention Name(s)

autologous tumor lysate-pulsed DC vaccination

Intervention Type

Biological

Intervention Name(s)

Tumor lysate-pulsed DC vaccination+0.2% resiquimod

Intervention Type

Biological

Intervention Name(s)

Tumor-lysate pulsed DC vaccination +adjuvant polyICLC

Primary Outcome Measure Information:

Title

Most effective combination of DC vaccine components

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Time to tumor progression and overall survival

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

PATIENT ELIGIBILITY Inclusion Criteria 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. 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. After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established. 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. 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 Subjects with an active infection. Inability to obtain informed consent because of psychiatric or complicating medical problems. Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator. Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception. 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. Subjects with organ allografts. Inability or unwillingness to return for required visits and follow-up exams. Subjects who have an uncontrolled systemic malignancy that is not in remission.

Facility Information:

Facility Name

University of Los Angeles, California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10350260

Citation

Liau LM, Black KL, Prins RM, Sykes SN, DiPatre PL, Cloughesy TF, Becker DP, Bronstein JM. Treatment of intracranial gliomas with bone marrow-derived dendritic cells pulsed with tumor antigens. J Neurosurg. 1999 Jun;90(6):1115-24. doi: 10.3171/jns.1999.90.6.1115.

Results Reference

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PubMed Identifier

16061868

Citation

Liau LM, Prins RM, Kiertscher SM, Odesa SK, Kremen TJ, Giovannone AJ, Lin JW, Chute DJ, Mischel PS, Cloughesy TF, Roth MD. Dendritic cell vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the local central nervous system tumor microenvironment. Clin Cancer Res. 2005 Aug 1;11(15):5515-25. doi: 10.1158/1078-0432.CCR-05-0464.

Results Reference

background

PubMed Identifier

15353342

Citation

Prins RM, Liau LM. Cellular immunity and immunotherapy of brain tumors. Front Biosci. 2004 Sep 1;9:3124-36. doi: 10.2741/1465.

Results Reference

background

PubMed Identifier

18669440

Citation

Prins RM, Cloughesy TF, Liau LM. Cytomegalovirus immunity after vaccination with autologous glioblastoma lysate. N Engl J Med. 2008 Jul 31;359(5):539-41. doi: 10.1056/NEJMc0804818. No abstract available.

Results Reference

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Dendritic Cell Vaccine for Patients With Brain Tumors

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